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The Efficacy and Safety of ZS801 in Chinese Hemophilia B Patients.

Hemophilia B Clinical Trial

Official title:
A Non-randomized, Open-label Study to Evaluate the Safety, Kinetics and Efficacy of a Single Intravenous Infusion of ZS801 in Hemophilia B Subjects With Endogenous FIX ≤2%.

Clinical Trial Summary

A non-randomized, open-label study to evaluate the safety, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.

Clinical Trial Description

This study will seek to determine the safety, kinetics and efficacy of a single IV infusion of ZS801. The dose level is 5.0×10^12vg/kg; Dose addition may occur based on the safety and FIX activity on steady state. Subjects will provide informed consent and then undergo screening assessments up to 6 weeks prior administration of ZS801. All subjects will undergo 52 weeks safety and efficacy observation. Then subjects ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05630651
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital
Contact Lei Zhang, MD
Phone +86 022-23909240
Email zhanglei1@ihcams.ac.cn
Status Not yet recruiting
Phase N/A
Start date December 2022
Completion date December 2028
View Details
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