Actively Recruiting
Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
Led by Suzhou Alphamab Co., Ltd. · Updated on 2026-04-22
70
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057. The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks. The participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment. Priority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.
CONDITIONS
Official Title
Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 12 to 65 years old at the time of signing informed consent, body weight 60 kg and BMI <28 kg/m�B2 at screening.
- For participants with inhibitors: tested positive for high-titer FVIII or FIX inhibitors (65 BU/mL) at screening; or tested positive for low-titer FVIII or FIX inhibitors (0.6 BU/mL or upper limit of normal [ULN] < inhibitor titer < 5 BU/mL) at screening and currently treated with bypassing agents (rFVIIa or PCC).
- For participants without inhibitors: severe or moderately severe Hemophilia A or B (FVIII or FIX activity level 62%); FVIII or FIX inhibitor test negative (<0.6 BU/mL) or below laboratory normal limits during screening; no history of inhibitors or inhibitor has been negative for at least 5 years before screening without reappearance; used coagulation factor replacement therapy for at least 100 exposure days before screening.
- Participants with inhibitors agree to avoid using PCC for breakthrough bleeding.
- Participants without inhibitors agree to be treated with standard half-life coagulation factors (FVIII or FIX) for breakthrough bleeding.
You will not qualify if you...
- Serious or poorly controlled chronic diseases or obvious systemic diseases.
- History of thromboembolic disease, current symptoms or signs related to thromboembolic disease, or treatment with thrombolytic/antithrombotic therapy.
- High-risk thrombosis factors such as atrial fibrillation, atherosclerotic diseases of major arteries, ischemic disease of major organs, vascular occlusive disease, autoimmune diseases with high thrombosis risk, or indwelling central venous catheter.
- Known or suspected hypersensitivity to any component of the trial product or related products.
- Major surgery within 3 months before screening or planned elective surgery during the study.
- Use of Emicizumab treatment within 6 months before screening.
- Previous gene therapy for hemophilia.
- Any other condition deemed inappropriate by the investigator for safety or data interpretation reasons.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yanrong Dong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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