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 enrolled 19 people in total — 10 in one group and 9 in the other. The trial was looking at how the body processed two different doses of a clotting factor treatment called rFVIIIFc (1,000 IU and 3,000 IU). This type of study is called a pharmacokinetic (PK) study, meaning it tracked how the treatment moved through the body over time — for example, how quickly it was absorbed, how long it stayed in the bloodstream, and how quickly the body cleared it. All 19 participants completed the measurement phases of the trial, and 17 of the 18 who entered the final treatment period also completed it. The reported data shows the following figures for the two doses. The total exposure to the treatment over time (a measure called "area under the curve") was reported as 2,888.9 units for the 1,000 IU dose and 2,646.3 units for the 3,000 IU dose. The peak level of the treatment detected in the blood was 122.2 IU/dL for the lower dose and 129.08 IU/dL for the higher dose. The reported "half-life" — meaning the time it took for the level in the blood to drop by half — was around 18.3 hours for the 1,000 IU dose and 17.5 hours for the 3,000 IU dose. How quickly the body cleared the treatment was reported as 1.807 mL/h/kg and 2.016 mL/h/kg respectively. The measure of how the treatment spread through the body (volume of distribution) was reported as 47.00 mL/kg and 48.65 mL/kg for the two doses. 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 1 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 been diagnosed with severe hemophilia A
- You have previously been treated with clotting factor products (either made from donated blood or lab-made) on at least 150 separate, documented occasions before the study starts
- You have never had a positive test for an "inhibitor" (an antibody that blocks clotting factor from working), and have never shown signs that your clotting factor treatment stopped working as expected — though a family history of inhibitors does not disqualify you
- A specific lab test at screening shows no measurable inhibitor activity in your blood
- Your platelet count (cells that help blood clot) is at least 100,000 per microliter of blood at screening
- If you are known to be HIV-positive, your immune cell count (CD4) is above 200 and your viral load is below 400 copies per milliliter of blood at screening
Who may not be able to join:
- The trial doctor believes you are at high risk of a bleeding episode during the first 5 days of the study
- You have previously received the specific study drug (rFVIIIFc) in any form
- You have another blood clotting disorder in addition to hemophilia A
- You have ever had a severe allergic reaction to any clotting factor product or intravenous immunoglobulin treatment
- You are currently taking, or are likely to need during the study, regular-strength aspirin — though low-dose aspirin taken for heart protection may be allowed (confirm with trial site)
- You have taken immune-suppressing medications (other than certain exceptions like some hepatitis C treatments or short courses of steroids) within the 12 weeks before the study starts
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
2 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 Activated Partial Thromboplastin Time (aPTT) Clotting Assay; Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.