Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

Hemophilia B Without Inhibitor Clinical Trial

Official title: Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

Status Not yet recruiting

Clinical Trial Summary

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.

Clinical Trial Description

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels. Nine subjects will be enrolled and administered with three different doses of KL001. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL001. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL001 for a total 5 years. ;

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B
• Hemophilia B Without Inhibitor

• NCT number: NCT06119659
• Study type: Interventional
• Source: Zhejiang University
• Contact: He Huang, PhD&MD
• Phone: +86 13605714822
• Email: huanghe@zju.edu.cn
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 20, 2023
• Completion date: July 10, 2025