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 165 adult men with severe haemophilia A (a condition where the blood does not clot properly). Participants were split into three groups: 118 people received a personalised (tailored) preventive dosing schedule, 24 received a fixed weekly preventive dose, and 23 received treatment only when a bleed occurred (on-demand). The trial was measuring how often bleeds happened, whether participants developed antibodies (called "inhibitors") that could interfere with the treatment, and a range of safety monitoring measures including side effects and changes in blood test results and vital signs. The reported data shows that across all three groups, zero participants developed inhibitory antibodies against the clotting factor treatment, whether measured among those with 50 or more days of exposure or across all participants regardless of exposure. For bleeding episodes, the reported average number of bleeds per person per year was approximately 1.6 in the tailored preventive group, 3.6 in the weekly preventive group, and 33.6 in the on-demand (treat when bleeding) group. Regarding side effects, the reported data shows that 80 participants in the tailored preventive group experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened after starting the study treatment), as did 18 in the weekly group and 10 in the on-demand group. Serious adverse events were reported in 5, 3, and 2 participants in those respective groups. Small numbers of participants across the groups also had notable changes in laboratory blood test results or vital signs such as blood pressure and pulse, with the specific figures varying by group and measurement type. 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 24227821) ↗
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 weigh at least 40 kg (about 88 lbs)
- You have been diagnosed with severe hemophilia A, meaning your body produces very little or no Factor VIII (the clotting protein)
- You have previously been treated with a Factor VIII product on at least 150 separate occasions, which have been recorded
- Your platelet count (the cells that help your blood clot) is at a healthy enough level of at least 100,000 cells per microliter
Who may not be able to join:
- You have previously developed inhibitors (antibodies that block Factor VIII treatments from working)
- You have problems with your kidneys or liver not working properly
- You have been diagnosed with another blood clotting disorder in addition to hemophilia A
- You have previously had a severe allergic reaction, including anaphylaxis, after receiving any Factor VIII product or intravenous immunoglobulin treatment
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
Incidence Rate of FVIII Inhibitor Development; Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs); Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline; Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs; Annualized Bleeding Rate; Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3; Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay); Elimination Half Life (t1/2; One-stage Clott...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.