Actively Recruiting
The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-21
6
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 65 years
- Confirmed diagnosis of hemophilia A with endogenous FVIII ≤2%
- Endogenous FVIII activity <1% or 1-2% with >10 bleeding events in the past year or on prophylaxis
- At least 150 prior exposure days to recombinant or plasma-derived FVIII products
- Agree to use reliable barrier contraception and avoid sperm donation for 52 weeks after treatment
- Able to understand, consent, comply with protocol, and willing to provide biological samples
You will not qualify if you...
- Hypersensitivity to study drug components or immunosuppressants
- Unable to tolerate immunosuppressants or steroid drugs
- Detectable FVIII inhibitor or history of FVIII inhibitor
- History or current serious diseases including malignancy, autoimmune disease, severe heart disease, liver disease, active hepatitis B or C infection
- Poorly controlled diabetes, uncontrolled blood pressure
- Laboratory abnormalities: low hemoglobin, low platelets, elevated liver enzymes, high bilirubin, high creatinine, low albumin
- Positive HIV or syphilis antibody
- AAV5 capsid neutralizing antibody titer >1:5
- Previous gene therapy or participation in other clinical trials recently
- Planned surgery within 52 weeks after infusion
- Recent blood donation or loss >400 mL within 3 months
- Epilepsy, mental illness, or other incapacity
- History of drug abuse or alcoholism
- Poor compliance or unlikely to complete follow-up
- Other clinically significant diseases or reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
L
Lei Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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