Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

Launched by CSL BEHRING · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called recombinant single-chain Factor VIII (rVIII-SingleChain) for men in China who have severe hemophilia A, a condition where the blood doesn’t clot properly. The goal is to understand how the body processes this treatment and to see how well it works and how safe it is when given two to three times a week. This study is important because it aims to gather information specific to Chinese participants, helping to bridge data from other parts of the world.

To participate in this trial, men must be Chinese, aged 65 or younger, and have severe hemophilia A, which means their Factor VIII levels are very low (less than 1%). They should also have a history of receiving Factor VIII treatments. Participants will be monitored throughout the trial to assess how the treatment affects their condition. It’s important to note that individuals with certain allergies, other bleeding disorders, specific medical treatments, or those using certain traditional medicines may not be eligible for this study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male Chinese participants \<= 65 years of age.
• • Participants with severe hemophilia A (FVIII activity \< 1%).
• • Participants who have received FVIII products for \>= 150 EDs (\>= 6 years of age) or \>= 50 EDs (\< 6 years of age).
• Exclusion Criteria:
• • Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
• • Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
• • Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
• • Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration of rVIII-SingleChain.
• • Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the participant's participation in the study.