Phase 3 Haemophilia Trial, Recruiting NCT07416526 Sponsor: Hoffmann-La Roche Condition: Haemophilia
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Phase 3 Haemophilia Trial, Recruiting

NCT07416526
Recruiting Phase 3

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 hereditary bleeding disorder caused by low levels of a clotting protein called Factor VIII)
  • You do not currently have "inhibitors" — meaning your body has not developed antibodies that block the clotting treatment from working
  • A test taken within the last 12 months has confirmed no inhibitors were present in your blood
  • You have detailed records of your bleeding episodes and hemophilia treatments from at least the past 6 months
  • If you are someone who could become pregnant, you agree to follow the contraception requirements set out by the trial

Who may not be able to join:

  • You have a known allergy or sensitivity to any of the study treatments or their ingredients, or any other allergy that the trial doctor feels makes participation unsafe
  • You are currently taking, or plan to take, certain medicines that affect your immune system (such as interferon or rituximab) — though HIV antiviral treatments are generally an exception (confirm with trial site)
  • You are planning to have surgery during the trial, apart from very minor procedures like a simple tooth extraction or a small skin procedure
  • You have a history of, or currently have, certain significant heart rhythm or electrical problems detected by a heart tracing (ECG), or a history of a heart attack
  • You are unwilling to receive blood or plasma products in an emergency situation
  • You have a history of, or risk factors for, serious irregular heart rhythms — for example, significant heart muscle problems or coronary (heart) disease

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
15 May 2026
Est. completion
23 September 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov