Recruiting

Testing a new preventive bleeding treatment for hemophilia

Plain-English translation of NCT07545395 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing , a new preventive medication designed to help people with hemophilia A or B reduce bleeding episodes. The study will follow participants for one year to see how safe and effective this medication is, including for people whose bodies have developed resistance (called inhibitors) to standard clotting factor treatments.

Many people with hemophilia need frequent infusions to prevent dangerous bleeding, and some develop inhibitors that make standard treatments less effective. This medication is being studied to see if it offers a safer, longer-lasting way to prevent bleeds for these patients.

Do you qualify?

You likely qualify if…

you are male, between 12 and 65 years old, and weigh at least 30 kg
you have been diagnosed with severe or moderately severe hemophilia A or B
you have had at least 100 exposure days of clotting factor replacement therapy before entering the study
you either have no inhibitors, or you have inhibitors and are currently being treated with bypassing agents
you are willing to use standard clotting factor therapy (not bypassing agents) if you experience breakthrough bleeding during the study

You likely don't qualify if…

you have serious or poorly controlled chronic health conditions
you have a history of blood clots or are currently being treated with blood-thinning medication
you have risk factors for blood clots, such as atrial fibrillation, atherosclerosis, or a central venous catheter
you have received emicizumab treatment within the past 6 months
you have ever received gene therapy for hemophilia

What participation looks like

Participants will receive preventive infusions of the medication for 52 weeks (one year). Some participants will receive an older version of the medication for the first 26 weeks, then switch to the new version for the second 26 weeks, to help researchers compare how well each works. Others will receive the new version for the entire year. Participants will be monitored regularly for safety and to measure how well the medication prevents bleeding.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Testing a new preventive bleeding treatment for hemophilia

What is this trial?

Do you qualify?

What participation looks like

Trial locations