Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
Lead Sponsor:
Suzhou Alphamab Co., Ltd.
Conditions:
Hemophilia A Without Inhibitor
Hemophilia B Without Inhibitor
Eligibility:
MALE
12-70 years
Phase:
PHASE3
Brief 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 screen...
Eligibility Criteria
Inclusion
- Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥30 kg and BMI \<28 kg/m\^2 at screening;
- Severe and moderately severe hemophilia A or hemophilia B (FVIII or FIX activity level ≤2%);
- FVIII or FIX inhibitor test is negative (\<0.6 BU/ml) or lower than the lower limit of laboratory normal values during the screening period;
- There is no history of FVIII or FIX inhibitors in the past; or there has been an inhibitor, but it has been at least 5 years since successful immune tolerance induction therapy (ITI), and the inhibitor has not reappeared (a positive inhibitor was detected after successful ITI);
- Use coagulation factor replacement therapy for no less than 100 exposure days before screening;
- Have not used Anti-TFPI drugs before;
- Be able and agree to elute the original hemophilia drugs.
- Participants who are enrolled into Part A must also meet the following criteria:
- ≥6 treated bleeding episodes within 26 weeks before screening;
- Receiving on-demand treatment, non-standard prophylaxis, or standard prophylaxis no more than 12 weeks before screening;
- Participants who are enrolled into Part B must also meet the following criteria:
- Being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen).
Exclusion
- Have serious or poorly controlled chronic diseases or obvious systemic diseases;
- Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
- Have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter;
- The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
- Known or suspected hypersensitivity to any constituent of the trial product or related products;
- Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study;
- Used Emicizumab treatment within 6 months before screening;
- Have received any gene therapy for hemophilia in the past;
- Other factors that the investigator deems inappropriate for participating in this trial, such as the presence of concomitant diseases, treatment or examination abnormalities that affect the subject's safety during the trial or affect the interpretation of trial results.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06569108
Start Date
April 1 2024
End Date
December 15 2026
Last Update
September 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020