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Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B

Study on CSL222 for young males with severe Hemophilia B.

Recruiting
138-206 years
Male
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a new medicine called CSL222 for boys aged 12 to 17 with severe or moderately severe hemophilia B. Hemophilia B is a bleeding disorder where the blood doesn't clot properly due to low levels of a protein called FIX. This study is open-label, meaning both doctors and patients know what treatment is being given, and it's single-dose, so participants get the treatment just once.

Participants must be male and have been on regular FIX treatments for at least two months. They must not have had any history of FIX inhibitors, which are substances that can block the treatment from working. Boys with certain health issues, like liver problems or other bleeding disorders, cannot join.

  • The study is single-dose, meaning only one treatment is given.
  • There is a lead-in period of at least 6 months where data is collected before treatment.
  • Participants must have been on continuous FIX prophylaxis before joining.

If you're considering this study, it's important to talk to your doctor to see if it’s right for you.

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Study details
    Hemophilia B

NCT07080905

CSL Behring

17 October 2026

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