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RECRUITING
NCT05523128
NA

The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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%.

Official title: 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%.

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2022-09-29

Completion Date

2025-10

Last Updated

2025-02-21

Healthy Volunteers

No

Conditions

Interventions

GENETIC

ZS802

A novel, bioengineered adeno-associated viral (AAV) vector carrying human factor VIII variant. The dose levels are as follows: 1. 2.0×10\^13vg/kg; 2. 6.0×10\^13vg/kg.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China