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 123 participants across four treatment groups. Sixty-three people were in the weekly preventive dosing group (Arm 1), 29 in the personalised-interval preventive dosing group (Arm 2), 27 in the on-demand (treat-when-bleeding) group (Arm 3), and 4 in a surgery management group (Arm 4). The trial was measuring things like abnormal blood test results and any unwanted medical events that occurred during the study, as well as how well bleeding episodes appeared to respond to injections of the study medicine (rFIXFc), a clotting factor treatment for haemophilia B. The reported data shows that, for potentially concerning laboratory (blood test) abnormalities, small numbers of participants were affected across the main three arms — for example, 2 participants in Arm 1, none in Arm 2, and 2 in Arm 3 showed one type of abnormality, while other specific abnormalities were seen in 1, 2, or 3 participants respectively. For unwanted medical events (called adverse events) that emerged during the study, 45 participants in the rFIXFc part of Arm 1, 23 in Arm 2, 20 in Arm 3, and 10 in Arm 4 reported at least one such event. Serious adverse events were reported in 5 participants in the rFIXFc part of Arm 1, 4 in Arm 2, 1 in Arm 3, and none in Arm 4. For the surgery group specifically, 2 participants had non-serious events and 1 had a serious event during the surgical period. For the secondary outcomes, the reported data shows that when participants rated how their bleeding episodes responded to the first injection, the percentage rated as "excellent or good" combined was around 78.8% in Arm 1, 74.6% in Arm 2, and 87.1% in Arm 3. When doctors rated each participant's overall response to treatment at the end of the study, approximately 74.5% of assessments in Arm 1, 73.2% in Arm 2, and 58.3% in Arm 3 were rated "excellent," with no assessments rated "ineffective" across any of the three arms. 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 24304002) ↗
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 are male and at least 12 years old, and you weigh at least 40 kg (about 88 lbs)
- You have been diagnosed with hemophilia B, with a very low level of Factor IX in your blood (2% or less)
- You have previously been treated with a Factor IX product on at least 100 separate occasions
- Your platelet count (a measure of cells that help blood clot) is at a healthy enough level of at least 100,000 cells per microliter (confirm with trial site)
Who may not be able to join:
- You have a history of developing inhibitors (antibodies that block the treatment) against Factor IX
- You have problems with your kidneys or liver
- You have been diagnosed with another blood clotting disorder in addition to hemophilia B
- You have previously had a severe allergic reaction (anaphylaxis) to any Factor IX product or to intravenous immunoglobulin (a type of treatment given through a drip)
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities; Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period; Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period; Incidence Rate of FIX Inhibitor Development; Annualized Bleeding Rate; Comparison of Annualized Bleeding Rates
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.