SCT800 for preventing and treating bleeds in previously untreated severe hemophilia A patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, uncontrolled Phase 3 study gives SCT800 as prophylaxis and to treat bleeding episodes in males with severe hemophilia A who are previously untreated. Participants must have FVIII activity <1% and be inhibitor-negative, with limited prior exposure to plasma products allowed. The study monitors safety (including inhibitor development, liver and kidney tests, and allergic reactions) and measures bleeding control on prophylaxis and response to treatment of bleeds. The trial is sponsored by Sinocelltech and conducted at Beijing Children's Hospital to continue collecting data on SCT800 in this population after its 2021 approval in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male subjects with severe hemophilia A (FVIII:C \< 1% in central laboratory tests)
* previously untreated with pdFVIII/rFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).
* FVIII inhibitor negative
* informed consent.

Exclusion Criteria:

* Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
* subjects with a history or family history of FVIII inhibitor formation;
* Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;
* Patients with other coagulation dysfunction diseases in addition to hemophilia A.
* International Normalized Ratio (INR) \> 1.5.

Where it's running

• Beijing children's hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Runhui Wu
• Email: wurunhuigcp@163.com
• Phone: +86-13370115037

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.