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 240 children with haemophilia A (a condition where the blood does not clot properly). The children came from two groups: 61 from one earlier study and 179 from three other related studies. The trial was measuring whether a clotting factor treatment called rFVIIIFc caused the body to develop "inhibitors" — which are antibodies that can block the treatment from working — and it also tracked how often participants experienced bleeding episodes. The reported data shows that for the primary outcome — checking whether any child developed inhibitors — the result was zero out of all participants across both age groups (children under 6, and children aged 6 to under 12) and across all study groups. No positive inhibitor results were reported. For bleeding episodes, the reported data shows that children on regular preventive dosing ("tailored prophylaxis") had annualized bleeding rates of approximately 1.18 episodes per year (younger age group) and 1.59 episodes per year (older age group) in the dedicated paediatric study, while children in the combined studies group on tailored prophylaxis had a rate of around 0.64 episodes per year. Higher rates were reported among children who only received treatment when bleeding occurred rather than on a preventive schedule. For the doctors' overall assessment of how participants responded to the treatment, the reported data shows that across both groups the large majority of recorded assessments were rated "excellent" (403 out of 428 responses in one group, and 1,061 out of 1,252 in the other), with a small number rated "effective" or "partially effective", and none rated "ineffective." 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 39091324) ↗
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 must have already taken part in and completed one of four specific previous studies related to rFVIIIFc (trial numbers NCT01181128, NCT02083965, NCT01458106, or NCT02502149)
- You must be able to understand the purpose and risks of the study and be willing to sign a consent form (or an assent form if applicable, for example for younger participants)
Who may not be able to join:
- You may not be able to join if blood tests have confirmed that your body has developed a high level of resistance (called "inhibitors") to the treatment being studied, measured at 5.00 BU/mL or above (confirm with trial site)
Important: There may be additional eligibility requirements not listed here, so 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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Any Positive Inhibitor Development
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.