Clinical Trial

Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Active, Not Recruiting Phase 3
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Summary
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use. Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 2:1 in Part A. Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B. Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in Control group will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks. Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-21.
Status change: Recruiting → Active, Not Recruiting 2025-09-16
Trial Details
NCT Number NCT06569108
Lead Sponsor Suzhou Alphamab Co., Ltd.
Conditions Hemophilia A Without Inhibitor, Hemophilia B Without Inhibitor
Enrollment 125 participants
Start Date 2024-04-01
Primary Completion 2026-10-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-17