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 (NCT01425723) involved 120 children with haemophilia B — 27 from one earlier study and 93 from another — who received a clotting factor treatment called rFIXFc. The trial was measuring whether children developed "inhibitors" (antibodies that can block a clotting treatment from working), how often bleeding episodes occurred, and several other related things such as how much of the treatment was used and how doctors rated participants' responses to the treatment. The reported data shows that, for the primary outcome — whether any child developed inhibitors — the number was zero across all groups, meaning no confirmed inhibitor development was recorded in any participant. For bleeding rates (the average number of bleeding episodes per person per year), the reported figures varied depending on the treatment schedule and age group: children under six years on a regular preventive schedule had a reported rate of around 1.04 episodes per year, those aged six to under twelve years had around 1.14 episodes per year, and participants from the other study group had a reported rate of around 2.26 episodes per year on a similar schedule, with higher rates recorded for those on an on-demand (treat-when-bleeding) schedule. For spontaneous joint bleeds specifically, rates of zero were reported for the younger children on preventive schedules, with small numbers reported for some other groups. Doctors' assessments of how participants responded to the treatment were recorded across hundreds of visits; the reported data shows the large majority of responses fell into the top two categories on the four-point scale, with very few in the lower two categories, and none recorded in the lowest category. 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 37283819) ↗
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 completed one of the following specific clinical trials: study 998HB102, study 9HB02PED, or another study involving the treatment called rFIXFc
- You must be able to understand what the study involves and its risks, and be willing to sign and date a consent form agreeing to take part
Who may not be able to join:
- People who have developed high levels of inhibitors (antibodies that block the treatment) at 5.00 BU/mL or above, as measured by a blood test (confirm with trial site if unsure what your levels are)
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
4 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.