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 (NCT01486927) enrolled 174 people with haemophilia A (a condition where the blood does not clot properly) who received a recombinant Factor VIII product called rVIII-SingleChain. Of those who started, 161 completed the trial and 13 did not. The trial was measuring several things: how well bleeding episodes were controlled, whether participants developed antibodies (called inhibitors) against the treatment, how often spontaneous bleeds occurred per year, and how the treatment performed during surgery. A smaller group also had their blood tested to see how the treatment moved through the body over time. The reported data shows that across all participants, around 92% of bleeding episodes were rated by the investigator as "excellent" or "good" in terms of how they responded — this rating applied whether participants were on a regular dosing schedule (prophylaxis) or were only treating bleeds as they occurred (on-demand). For the on-demand group, the reported average number of spontaneous bleeds per year was 11.73, while for those on the regular dosing schedule it was reported as 0.00. In the surgical sub-study, which covered 16 operations, 100% of surgeries received an "excellent" or "good" rating. Importantly, the reported data shows that none of the 174 participants developed inhibitors (antibodies that can reduce how well Factor VIII works) during the trial period. The reported data also includes some blood-level measurements from a pharmacokinetic (how the body processes a medicine) sub-study, showing figures for how much of the treatment was present in the blood over time and the peak level reached, though the full details of these comparisons were not broken down further in the submitted results. 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 ↗ · Read the linked publication on PubMed (PMID 27330001) ↗
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 been diagnosed with severe hemophilia A, meaning your Factor VIII activity level is less than 1% (as shown in your medical records).
- You are male and between 18 and 65 years old (for Parts 1 and 2 of the trial).
- You are male and between 12 and 65 years old (for Part 3 of the trial).
- You have previously used or are currently using Factor VIII treatment products, and have received more than 150 treatment sessions with a Factor VIII product.
- You are willing and able to give written consent to take part before any study procedures begin.
Who may not be able to join:
- You have ever had, or currently have, antibodies that work against Factor VIII (called "inhibitors").
- A close blood relative (parent, sibling, or child) has a history of developing Factor VIII inhibitors.
- You have taken part in another clinical trial or used an experimental medicine within the 30 days before starting this study.
- You have received cryoprecipitate, whole blood, or plasma within 30 days before starting the study.
- You have had an allergic reaction or severe allergic response to any Factor VIII product or to hamster proteins.
- You have any other blood clotting disorder, whether inherited or developed, apart from hemophilia A.
- Your platelet count (a measure of clotting cells in your blood) was below 100,000 per microliter at your screening visit.
- You are HIV positive with a very low immune cell count (CD4 count below 200/mm³), either in your medical history or at the time of screening (confirm with trial site).
- You are currently receiving intravenous (IV) treatments that affect the immune system, such as immunoglobulin therapy or long-term steroid treatment taken by mouth or injection.
- Your liver enzyme levels (called AST or ALT) are more than 5 times higher than the normal range at your screening visit.
- Your kidney function marker (creatinine) in your blood is more than twice the normal upper limit at your screening visit.
- You have had a blood clot-related event in the past 3 months, such as a deep vein thrombosis, stroke, pulmonary embolism, heart attack, or arterial blood clot.
- You have had a life-threatening bleed, major surgery, or major joint surgery within the 3 months 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: Program Director, CSL Behring
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
Treatment Success; Inhibitor Formation to FVIII; Annualized Spontaneous Bleeding Rate; Treatment Success During the Peri-operative Surgical Sub-study
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.