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 (NCT04083781) enrolled 133 people in total across four groups. Participants either had haemophilia and were not receiving any preventive (prophylaxis) treatment, or they were assigned to receive a medicine called concizumab as a daily preventive injection. The trial was primarily measuring how often treated bleeds — both spontaneous (happening without a clear cause) and injury-related — occurred per year, expressed as an "annualised bleeding rate" (ABR), which is simply the estimated average number of treated bleeds a person would have in one year. The reported data shows that in the group who received no preventive treatment (on-demand only), the ABR for treated spontaneous and traumatic bleeds was 9.8 events per year. In the group who switched to concizumab preventive treatment, the reported ABR was 0.0 events per year. For secondary measures, the reported rate of spontaneous bleeds alone was 8.4 per year in the no-prophylaxis group and 0.0 in the concizumab group. Reported joint bleed rates were 6.5 per year (no prophylaxis) versus 0.7 per year (concizumab group). The reported data also shows changes in self-reported physical wellbeing scores (measured on a standard quality-of-life questionnaire) over 24 weeks, with all four groups showing increases in scores for both bodily pain and physical functioning, ranging from 1.6 to 9.3 points depending on the group and measure. 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 41499759) ↗
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, Active, Not Recruiting
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 agree to participate and sign a consent form before any trial activities begin (a parent or guardian may sign for younger participants).
- You must be male and aged 12 years or older at the time of signing the consent form.
- You must have been born with Haemophilia A or B of any severity, and have a documented history of inhibitors (antibodies that block the normal clotting treatment) at a certain level or above.
- You must have been prescribed, or have a medical need for, bypass treatments (special clotting medicines used when inhibitors are present) in the 24 weeks before the screening visit — unless you were already enrolled in a related previous trial.
Who may not be able to join:
- You may not be eligible if you have a known or suspected allergy to any ingredient in the trial medicine or similar medicines.
- You may not be eligible if you have any other blood clotting disorder, either inherited or developed over time, beyond your haemophilia.
- You may not be eligible if you are currently undergoing or planning to start Immune Tolerance Induction (a treatment aimed at removing inhibitors) (confirm with trial site).
- You may not be eligible if you have a history of blood clots in your veins or arteries (such as a heart attack, stroke, deep vein thrombosis, or pulmonary embolism), or if you currently show signs of or are being treated for such conditions, or if the trial doctor considers you to be at high risk of developing blood clots due to factors such as high cholesterol, diabetes, high blood pressure, obesity, smoking, or a family history of clotting problems.
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: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
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
Rate of Treated Spontaneous and Traumatic Bleeding Episodes
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.