This page shows what was measured, who it was measured in, and what that does not settle.
What Recombinant Factor VIIa does in the body
Stopping bleeding in people with haemophilia whose bodies have learned to destroy the replacement clotting factor they used to be given
Clotting normally runs as a chain of enzymes, each switching on the next. Haemophilia breaks one link in the middle of that chain, and in some people the replacement for that link is destroyed by their own antibodies. Factor VIIa joins the chain higher up, at the point where an injured blood vessel first exposes a protein called tissue factor. Given in large amounts it generates thrombin directly on the surface of platelets gathered at the wound, skipping the broken link entirely.
What happened in people
Increased thrombin generation in haemophilic blood at concentrations as low as 10 nM in a tissue-factor-initiated in vitro model
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That limiting haematoma expansion improves survival or function after intracerebral haemorrhage — reduced in three trials, beneficial in none
Where it acts
The surface of the injured vessel wall and of activated platelets, where tissue factor is exposed
Kind of result
A step measured inside a person
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 124 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Functional outcome at 180 days by modified Rankin Scale
✗ The study did not show it
Who was studied
FASTEST (NCT03496883) — rFVIIa within 2 hours of intracerebral haemorrhage
Adjusted common odds ratio 1.09 (95% CI 0.79 to 1.51), p = 0.61; prespecified futility stopping criteria met at the second interim analysis
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Life-threatening thromboembolic complications within 4 days in 15 of 328 on treatment against 4 of 298 on placebo, relative risk 3.41 (95% CI 1.14 to 10.15, p=0.020). Haematoma growth was again reduced, by 3.7 mL, which is the endpoint that has never mattered.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Poor outcome, defined as severe disability or death on the modified Rankin scale at 90 days
✗ The study did not show it
Who was studied
FAST (NCT00127283) — phase 3 rFVIIa for acute intracerebral haemorrhage
How many people
841
Study design
Phase 3 randomised placebo-controlled trial, three arms
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Poor outcome 24% on placebo, 26% at 20 micrograms per kilogram, 29% at 80 micrograms per kilogram — no significant difference; haematoma growth reduced by 3.8 mL at the high dose (95% CI 0.9 to 6.7, p=0.009)
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Arterial thromboembolic events were more frequent at 80 micrograms per kilogram than on placebo, 9% against 4% (p=0.04), while overall thromboembolic serious adverse events were similar across arms.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Percent change in intracerebral haemorrhage volume at 24 hours
✓ The study showed what it set out to show
Who was studied
Phase 2 dose-ranging trial of rFVIIa in intracerebral haemorrhage
How many people
399
Study design
Phase 2 randomised placebo-controlled dose-ranging trial, four arms
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean volume increase 29% on placebo against 16%, 14% and 11% at 40, 80 and 160 micrograms per kilogram (p=0.01); 90-day mortality 29% against 18% pooled (p=0.02); death or severe disability 69% against 55%, 49% and 54% (p=0.004)
Repeated elsewhere
Failed to Replicate
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Serious thromboembolic events, mainly myocardial or cerebral infarction, occurred in 7% of treated patients against 2% on placebo (p=0.12). The clinical benefits reported here were secondary outcomes and failed to replicate in two subsequent trials totalling 1,467 patients.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Mortality and thromboembolism in intracranial haemorrhage, cardiac surgery, trauma, liver transplantation and prostatectomy
✗ The study did not show it
Who was studied
Pooled off-label evidence across five in-hospital indications, to December 2010
How many people
64
Study design
Systematic review of 16 randomised trials, 26 comparative and 22 non-comparative observational studies
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
No mortality reduction at any dose or indication; arterial thromboembolism risk difference 0.03 (95% CI 0.01 to 0.06) at medium dose and 0.06 (95% CI 0.01 to 0.11) at high dose in intracranial haemorrhage; 0.05 (95% CI 0.01 to 0.10) in cardiac surgery
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The sample size field here is the number of included studies, not patients, because the review pools heterogeneous populations across five indications. The reviewers rated the strength of evidence low for most outcomes and could not exclude publication bias.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Recombinant Factor VIIa
What a person takes: Intravenous bolus injection after reconstitution, repeated at intervals for a bleed.
The measurement behind this step
Supplied as a lyophilised powder in 1 mg, 2 mg and 5 mg vials with a histidine diluent, reconstituted to approximately 1 mg/mL and given as a slow intravenous injection. Repeat doses are given until the bleeding episode is controlled. Room-temperature stability is what the RT designation refers to and is a genuine advance for a patient who has to carry the drug.
Getting in
Reconstituted from a powder and injected over a couple of minutes
Supplied as a freeze-dried powder in vials of one, two or five milligrams, mixed with its own diluent and given straight into a vein.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Each vial contains rFVIIa with sodium chloride, calcium chloride, glycylglycine, polysorbate 80, mannitol, sucrose and methionine, reconstituted in 10 mmol histidine to approximately 1 mg/mL. In FASTEST the dose was 80 micrograms per kilogram given intravenously over two minutes.
The protein carries a specialised end that only works when it is loaded with calcium. That end lets it stick to the membranes exposed where a vessel has been torn.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The gamma-carboxyglutamic acid domain, produced by vitamin-K-dependent carboxylation during manufacture, binds calcium ions and through them the anionic phospholipid exposed on damaged membranes and activated platelets. Without carboxylation the molecule is inert, which is why that modification governs the yield of the whole process.
It pairs with tissue factor, the body’s own alarm protein
Tissue factor is normally hidden inside vessel walls and is only exposed when one is damaged. Factor VIIa partners with it, and that partnership is what starts clotting at the site of an injury and nowhere else.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The factor VIIa-tissue factor complex activates factor X to Xa and factor IX to IXa. Restricting the reaction to sites of tissue factor exposure is the design feature that is supposed to keep the effect local, and it is also why circulating tissue factor in sepsis, disseminated intravascular coagulation or crush injury converts the drug into a systemic thrombotic hazard.
At high doses it works on platelets directly, skipping the broken link
Given in the amounts used clinically, it also makes thrombin straight on the surface of platelets already gathered at the wound — which is how it works in haemophilia, where the usual route through the cascade is blocked.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
In an in vitro model of tissue-factor-initiated coagulation with the contact pathway blocked by corn trypsin inhibitor, added rFVIIa increased both the rate and level of thrombin generation in normal and haemophilia A blood, with an effect at concentrations as low as 10 nM. Escalating doses in haemophilic platelet-rich plasma produce a dose-dependent rise in thrombin generation. This platelet-surface pathway is independent of factors VIII and IX, and therefore of the inhibitor antibodies against them.
Thrombin builds the fibrin plug — and the bleed grows less
The thrombin generated converts fibrinogen into fibrin and a plug forms. In brain haemorrhage this reliably makes the bleed smaller than it would have been.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Absolute reductions in 24-hour haematoma growth against placebo of 3.3 to 5.8 mL in the 2005 phase 2, 3.8 mL in the 2008 phase 3 and 3.7 mL in FASTEST — three independent randomised confirmations of the same pharmacodynamic effect across twenty-one years.
And the patient is no better, and more likely to have a clot
None of that made people less disabled or more likely to survive. What it did do was raise the rate of dangerous clots — three times over in the most recent trial.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Poor outcome at 90 days in FAST: 24% on placebo, 29% at 80 micrograms per kilogram. Modified Rankin at 180 days in FASTEST: adjusted common odds ratio 1.09 (95% CI 0.79 to 1.51, p=0.61). Life-threatening thromboembolism within four days in FASTEST: relative risk 3.41 (95% CI 1.14 to 10.15, p=0.020). Arterial thromboembolic events in FAST at 80 micrograms per kilogram: 9% against 4% on placebo (p=0.04).
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Haemophilia patients with inhibitors, people with acquired haemophilia, and people with the rare inherited deficiency of factor VII itself. Everything else this drug has been given for is off-label.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of SEVENFACT for the treatment and control of bleeding episodes have not been established in children < 12 years of age.”
US prescribing information · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · read 2026-08-30
On older people, the label states: “Safety and effectiveness of SEVENFACT in patients >65 years of age have not been evaluated in clinical trials (Study 1 and Study 2).”
US prescribing information · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no adequate and well-controlled studies using SEVENFACT in pregnant women to determine whether there is a drug-associated risk.”
US prescribing information · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of SEVENFACT in human milk, the effect on the breastfed infant, and the effects on milk production.”
US prescribing information · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · read 2026-08-30
Where the result stopped carrying
FAST, the confirmatory phase 3, found no difference in poor outcome at 90 days across 841 patients while confirming the haematoma effect
FASTEST met its prespecified futility stopping criteria at the second interim analysis after 626 patients
A systematic review of five off-label indications found no mortality benefit anywhere and increased arterial thromboembolism in intracranial haemorrhage and cardiac surgery
Thrombosis has been reported in women given the drug for post-partum haemorrhage, an off-label use recorded in the label’s own warnings section
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: Still the standard bypassing agent for haemophilia with inhibitors, acquired haemophilia and congenital factor VII deficiency, where the evidence supports it
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Supplied as a lyophilised powder in 1 mg, 2 mg and 5 mg vials with a histidine diluent, reconstituted to approximately 1 mg/mL and given as a slow intravenous injection.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: Repeat doses are given until the bleeding episode is controlled. Room-temperature stability is what the RT designation refers to and is a genuine advance for a patient who has to carry the drug.
No source is stored against this line.
Where it is registered
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No register entry is recorded.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Carries a boxed warning for serious thrombotic adverse events with use outside the labelled indications, citing clinical studies showing increased arterial thromboembolic events outside the approved indications and both fatal and non-fatal thrombotic events in postmarketing surveillance. Within the licence, thrombotic events of possible or probable relationship occurred in 0.28% of bleeding episodes treated. Risk is increased by disseminated intravascular coagulation, advanced atherosclerotic disease, crush injury, septicaemia and concomitant prothrombin complex concentrate, all of which supply circulating tissue factor. Patients with factor VII deficiency should be monitored for prothrombin time, factor VII coagulant activity and antibody formation. Hypersensitivity has been reported and the product is manufactured in medium containing newborn calf serum.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravenous bolus injection after reconstitution, repeated at intervals for a bleed
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Repeat doses are given until the bleeding episode is controlled. Room-temperature stability is what the RT designation refers to and is a genuine advance for a patient who has to carry the drug.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
Sevenfact is intravenous at 3 DOSAGE FORMS AND STRENGTHS SEVENFACT is a white to off-white lyophilized powder for reconstitution in a colorless solution for injection., recorded as fda label in effect 2025-11-19 in the United States.
US prescribing information · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Recombinant Factor VIIa studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That limiting haematoma expansion improves survival or function after intracerebral haemorrhage — reduced in three trials, beneficial in none
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the mortality benefit in the 399-patient phase 2 was a real effect rather than a secondary endpoint in a small trial
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That giving the drug earlier was the missing ingredient; FASTEST gave it at a mean of 100 minutes from onset and stopped for futility
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a bypassing agent which works in haemophilia will help any bleeding patient — the generalisation the boxed warning was written to stop
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Recombinant Factor VIIa are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
A 399-patient trial said it cut deaths by a third. It did not.
In plain words
In 2005 a randomised trial of 399 patients with brain haemorrhage reported 18% mortality on factor VIIa against 29% on placebo, and better function at 90 days. Three years later a trial twice the size, testing the same doses, found nothing.
What was measured
Poor outcome (severe disability or death on the modified Rankin scale) at 90 days, and mean percentage haematoma growth at 24 hours
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The phase 2 trial randomised 399 patients within three hours of onset to placebo or 40, 80 or 160 micrograms per kilogram. Haematoma growth was reduced by 3.3, 4.5 and 5.8 mL respectively (p=0.01), death or severe disability fell from 69% to 55%, 49% and 54% (p=0.004 for the pooled comparison), and 90-day mortality fell from 29% to 18% pooled across the treatment arms (p=0.02). Serious thromboembolic events, mainly myocardial or cerebral infarction, occurred in 7% against 2% (p=0.12). The phase 3 FAST trial then randomised 841 patients within four hours to placebo, 20 or 80 micrograms per kilogram. The 80 microgram arm again reduced haematoma growth — 11% expansion against 26% on placebo, p<0.001, a 3.8 mL absolute reduction (95% CI 0.9 to 6.7, p=0.009) — and produced no difference whatever in poor clinical outcome: 24% on placebo, 26% at 20 micrograms, 29% at 80 micrograms. Arterial thromboembolic events were more frequent at 80 micrograms than on placebo, 9% against 4% (p=0.04).
Written into the record, not signed off as a reviewed claim
Given within two hours, it still failed — and tripled life-threatening clots
In plain words
The last objection was that the drug had been given too late. FASTEST gave it within two hours of the stroke, in patients selected to be the ones most likely to benefit. It was stopped for futility. Life-threatening clots were more than three times as common.
What was measured
Modified Rankin scale at 180 days, and life-threatening thromboembolic events within four days
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
FASTEST was a multicentre, double-blind, randomised, placebo-controlled, adaptive phase 3 trial at 93 sites across six countries, screening 3,288 patients to randomise 626 between December 2021 and October 2025. Entry required a spontaneous intracerebral haemorrhage of 2 to 60 mL, limited intraventricular extension, a Glasgow Coma Scale of at least 8, no anticoagulation and no recent ischaemic event, with study drug given within two hours of onset — mean time to administration was 100 minutes. The trial met its prespecified futility stopping criteria at the second interim analysis. The adjusted common odds ratio for modified Rankin scale at 180 days was 1.09 (95% CI 0.79 to 1.51, p=0.61). Life-threatening thromboembolic complications within four days occurred in 15 of 328 on treatment against 4 of 298 on placebo, relative risk 3.41 (95% CI 1.14 to 10.15, p=0.020). Haematoma growth was again reduced, by 3.7 mL (95% CI 1.9 to 5.4), and combined intracerebral plus intraventricular growth by 5.2 mL (95% CI 2.8 to 7.6).
Written into the record, not signed off as a reviewed claim
The haematoma really does stop growing. Three times over.
In plain words
Every one of the three randomised trials found the same thing: give this drug and the bleed in the brain grows less. The size of that effect has been remarkably consistent across twenty-one years — and it has never once translated into a better patient.
What was measured
Absolute reduction in intracerebral haematoma volume growth at 24 hours against placebo, across three randomised trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Absolute reductions in 24-hour haematoma growth against placebo: 3.3 to 5.8 mL across dose arms in the 2005 phase 2 (p=0.01); 3.8 mL at 80 micrograms per kilogram in the 2008 phase 3 (95% CI 0.9 to 6.7, p=0.009); 3.7 mL in FASTEST (95% CI 1.9 to 5.4), with 5.2 mL for combined intracerebral and intraventricular volume. This is one of the most reproducible pharmacodynamic effects in acute stroke medicine. Haematoma expansion is also one of the strongest prognostic markers in intracerebral haemorrhage. The two facts together are exactly what makes this drug the definitive case study in the difference between a marker and a mechanism of harm you can intervene on.
Written into the record, not signed off as a reviewed claim
Off-label, across five indications, it reduced no deaths and added clots
In plain words
A systematic review looked at every off-label use — brain haemorrhage, cardiac surgery, trauma, liver transplantation, prostate surgery. No mortality benefit anywhere. Arterial clots increased with medium and high doses.
What was measured
Mortality and arterial thromboembolism risk differences across five off-label indications
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Yank et al. searched ten databases through December 2010 and included 16 randomised controlled trials, 26 comparative observational studies and 22 non-comparative observational studies across five off-label in-hospital indications. For intracranial haemorrhage, mortality was not improved at any dose, while arterial thromboembolism increased at medium dose (risk difference 0.03, 95% CI 0.01 to 0.06) and high dose (risk difference 0.06, 95% CI 0.01 to 0.11). For adult cardiac surgery there was no mortality difference and an increased risk of thromboembolism (risk difference 0.05, 95% CI 0.01 to 0.10). For body trauma there was no difference in mortality or thromboembolism, with a reduced risk of acute respiratory distress syndrome. Mortality was consistently higher in the observational studies than in the trials. The reviewers rated the amount and strength of evidence low for most outcomes and could not exclude publication bias.
Written into the record, not signed off as a reviewed claim
Inside its licence the thrombosis rate is 0.28% of bleeds treated
In plain words
Used for what it is approved for, the drug is comparatively safe: about three thrombotic events per thousand bleeding episodes treated. The number is much higher in acquired haemophilia, at four in a hundred.
What was measured
Rate of thrombotic events of possible or probable relationship, per bleeding episode treated, within the approved indications
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The NovoSeven RT label reports that in clinical trials within the approved indications, thrombotic events of possible or probable relationship occurred in 0.28% of bleeding episodes treated: 0.20% in haemophilia patients with inhibitors and 4% in acquired haemophilia. Patients with disseminated intravascular coagulation, advanced atherosclerotic disease, crush injury or septicaemia, and those given prothrombin complex concentrates concomitantly, are identified as being at increased risk because of circulating tissue factor or predisposing coagulopathy. The contrast between 0.28% inside the licence and a tripled relative risk of life-threatening thromboembolism in FASTEST is the central safety fact about this molecule: the risk is a function of who receives it.
Source
NovoSeven RT FDA-approved prescribing information, section 5.1 Thrombotic Events within the Licensed Indications
Role in the trial
Not matched to a registered study
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Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The FDA put the off-label problem in the boxed warning itself
In plain words
Most boxed warnings describe a risk of the drug. This one describes a risk of using the drug for things it was not approved for, and says the evidence for that risk comes from the trials of those very uses.
What was measured
That a drug which improves a coagulation endpoint in one disease will help anyone who is bleeding — the generalisation the boxed warning exists to stop
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The NovoSeven RT boxed warning reads: "Serious thrombotic adverse events are associated with the use of NovoSeven RT outside labeled indications... Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications. Fatal and non-fatal thrombotic events have been reported... Safety and efficacy of NovoSeven RT has not been established outside the approved indications." Section 5.2 attributes the finding to two meta-analyses of placebo-controlled trials in populations outside the approved indications, and separately records thrombosis in women treated for post-partum haemorrhage. A regulator writing a boxed warning about prescribing behaviour rather than about the molecule is unusual, and it is a direct consequence of a decade in which the drug was used far outside its licence on the strength of one phase 2 trial.
Source
NovoSeven RT FDA-approved prescribing information, boxed warning and section 5.2 Thrombotic Events outside the Licensed Indications
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A recombinant clotting factor that bypasses the missing links in haemophilia and works there, which was then given for twenty years to people bleeding into the brain on the strength of a 399-patient trial that found lower mortality — an effect that vanished in an 841-patient phase 3 in 2008 and vanished again in a 626-patient trial stopped for futility in 2026, both of which confirmed the haematoma shrinks and neither of which found any benefit to the patient.
Recorded evidence blocks (5)
Q1
On the Recombinant Factor VIIa label: indicated for what?
"SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.": indications and usage on Recombinant Factor VIIa's label. DailyMed label · b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 · 2026-08-30
Q2
5 registered trials of Recombinant Factor VIIa — at which phases?
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