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 84 adult participants, all of whom received a clotting factor treatment called rVIII-SingleChain, which is a type of Factor VIII (a protein the blood needs to clot properly) used to manage haemophilia A. Of the 84 who started, 65 completed the study and 19 did not. The trial was measuring how well the treatment controlled bleeding episodes, both when used as a regular preventive (prophylaxis) regimen and when used on-demand (only when a bleed occurred). The reported data shows that, across 347 treated bleeding episodes in the group assessed for effectiveness, 96.3% were rated as a treatment success — meaning the investigator judged the outcome as either "excellent" or "good" on a four-point scale. Looking at how many infusions (doses) were needed per bleeding episode, the reported data shows that 85.9% of bleeds were managed with just one infusion, 9.8% needed two, 2.3% needed three, and 2.0% required more than three. For the annualised bleeding rate — that is, the estimated number of treated bleeds per year — the reported data shows 78.56 bleeds per year in the on-demand group and 3.69 per year in the prophylaxis group. The reported data also shows that participants on the on-demand regimen used an average of approximately 2,429 IU/kg (units of the treatment per kilogram of body weight) per year, while those on prophylaxis used approximately 4,541 IU/kg per year. 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 been diagnosed with severe hemophilia A, meaning your Factor VIII levels are less than 1% (confirmed in your medical records)
- The patient is a boy under 12 years of age
- The patient has already been treated with a Factor VIII product more than 50 times before
- For the part of the study involving medication tracking (PK), the patient must have previous data available on how their body responded to Factor VIII treatment (confirm with trial site)
- The doctor running the trial believes the patient and their parent or legal guardian are willing and able to follow all study rules and requirements
Who may not be able to join:
- The patient has ever had, or currently has, antibodies that fight against Factor VIII (called "inhibitors")
- The patient has taken part in another medical research study involving an experimental product within the last 30 days
- The patient has received cryoprecipitate, whole blood, or plasma transfusions within the last 30 days
- The patient has had an allergic reaction or severe allergic response to any Factor VIII product or to hamster proteins
- The patient is currently receiving treatments that affect the immune system through a drip, such as immunoglobulin or long-term steroid medicines
- The patient's liver function blood test results are more than 5 times higher than the normal range (confirm with trial site)
- The patient's kidney function blood test results are more than 2 times higher than the normal range (confirm with trial site)
- The patient has had a blood clot, stroke, pulmonary embolism, heart attack, or arterial blockage within the last 3 months
- The patient has had a life-threatening bleed, major surgery, or joint surgery within the 3 months before starting the trial
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Treatment Success
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.