Phase 3 Haemophilia Trial, 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 have been diagnosed with severe or moderate congenital hemophilia A (a inherited bleeding disorder where the body makes very little or no clotting Factor VIII), with or without antibodies (called inhibitors) that block Factor VIII from working.
- You have mild congenital hemophilia A but have developed long-lasting inhibitors that have kept your Factor VIII levels very low for at least 12 months.
- You have records of inhibitor test results from within the past 12 months before joining the trial.
- You have documented records of your bleeding episodes and any treatments you have received (such as Factor VIII, bypassing agents, or emicizumab) for at least the last 6 months.
- If you currently only treat bleeds as they happen (rather than taking regular preventive treatment), you must agree to switch to a regular preventive treatment as part of the trial.
Who may not be able to join:
- You have a known allergy or sensitivity to any of the study drugs or their ingredients, or any other allergy that the study doctor feels makes it unsafe for you to participate.
- You are currently taking or plan to take certain medicines that affect the immune system (such as interferon or rituximab), unless it is antiretroviral therapy for HIV.
- You are unwilling to receive blood or plasma products in an emergency if needed.
- You are planning to have surgery (other than minor procedures like a simple tooth extraction or draining a small infection) during the study period.
- You have a history of serious heart rhythm problems, or heart conditions that could put you at risk for them, such as significant heart muscle weakness, an enlarged heart muscle, or coronary heart disease.
- You have or have had an abnormal heart tracing (ECG) considered medically significant, or a history of a heart attack (confirm with trial site if you are unsure whether your heart history applies).
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 Trials, Hoffmann-La Roche
Phone: 888-662-6728 (U.S. Only)
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
Primary endpoints
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
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.