NCT05523128 The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.
| NCT ID | NCT05523128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Hemophilia A |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2025-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A non-randomized, open-label, dose-escalation study to evaluate the safety, tolerability, kinetics and efficacy of a single intravenous infusion of ZS802 in hemophilia A subjects with endogenous FVIII ≤2%.
Eligibility Criteria
Inclusion Criteria: 1. Male ≥18 years and ≤65years of age; 2. Confirmed diagnosis of hemophilia A, and endogenous FVIII ≤2%: 1. \<1% (\<1 IU/dL) endogenous FVIII activity levels as historically documented by a certified laboratory or screening data results; OR 2. 1%-2% (1-2 IU/dL) endogenous FVIII activity levels and \>10 bleeding events per year (in the last 52 weeks prior to screening); OR 3. 1%-2% (1-2 IU/dL) endogenous FVIII activity levels and on prophylaxis; 3. Have had ≥150 prior exposure days (EDs) to any recombinant and/or plasma-derived FVIII protein products. 4. Agree to use reliable barrier contraception and prohibition of sperm donation until 52 weeks after the administration of ZS802. 5. Subjects voluntarily participate and are fully informed, fully understand the research and can comply with the requirements of the research protocol, are willing to complete the research as planned, and voluntarily cooperate with the provision of biological samples for testing. Exclusion