Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial looked at how a clotting factor medicine called rFVIIIFc (a recombinant Factor VIII) behaved in the body after it was given as an injection. The trial was specifically comparing two different manufacturing scales of the same medicine — a smaller production batch (called "2K") and a larger production batch (called "15K") — to see whether the larger-scale product moved through the body in a similar way to the smaller-scale version. A total of 24 participants took part in the first comparison stage, and 23 of those went on to a further stage. Twenty-three participants then took part in the second stage, split across two different vial strengths of the 15K product. The reported data shows that the two main things being measured were: (1) the total exposure to the medicine over time (called AUCinf — essentially how much of the medicine was present in the blood and for how long), and (2) how much the medicine level in the blood rose per unit of dose given (called incremental recovery). For the smaller-batch (2K) product, the reported AUCinf figure was 2,255.6 IU·h/dL, and for the larger-batch (15K) product it was 2,425.8 IU·h/dL. The incremental recovery figures were 2.684 IU/dL per IU/kg for the 2K product and 2.700 IU/dL per IU/kg for the 15K product. The reported data also shows that the peak level of the medicine in the blood (Cmax) was 133.20 IU/dL for the 2K product and 134.67 IU/dL for the 15K product; the time for the medicine level to fall by half (half-life) was about 14.2 hours for 2K and 14.8 hours for 15K; the rate at which the body cleared the medicine was 2.18 mL/h/kg for 2K and 2.04 mL/h/kg for 15K; and the estimated volume in which the medicine distributed through the body was 43.80 mL/kg for 2K and 43.01 mL/kg for 15K. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Haemophilia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have a severe form of Hemophilia A, confirmed by a blood test at the study clinic showing very low levels of a clotting protein called Factor VIII (less than 1%).
- You have previously been treated with Factor VIII products (from any source) on at least 150 separate occasions, documented before the study begins (note: treatment with fresh frozen plasma does not count toward this number).
- You have never had a positive test for "inhibitors" (antibodies that block Factor VIII from working), and you have shown no signs that Factor VIII treatments have become less effective for you (a family history of inhibitors does not disqualify you).
- A blood test at the screening visit confirms there are no measurable inhibitors to Factor VIII in your blood.
Who may not be able to join:
- You are currently enrolled in another clinical study involving an experimental or investigational treatment within the past 30 days, or you have previously taken part in any of these specific Biogen studies: NCT01027377, NCT01181128, NCT01458106, NCT02083965, or NCT01454739.
- You have already taken part in this particular study before.
- You have another serious ongoing health condition that the study doctor believes makes it unsafe or unsuitable for you to participate.
- You have another blood clotting disorder in addition to Hemophilia A.
- You have previously had a severe allergic reaction (including anaphylaxis) to Factor VIII products or to intravenous immunoglobulin treatments.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Bioverativ Therapeutics Inc.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage Activated Partial Thromboplastin Time (aPTT) Clotting Assay for Pharmacokinetic Assessment 1 (PK1) and Pharmacokinetic Assessment 2 (PK2); Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK1 and PK2
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.