Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors (NCT06312475) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors
China53 participantsStarted 2024-01-09
Plain-language summary
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration.
Who can participate
Age range12 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI \<28 kg/m\^2 at screening;
✓. The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value \< inhibitor titer \< 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
✓. ≥6 treated bleeding episodes within 26 weeks before screening;
✓. Have not used TFPI antibody drugs before;
✓. Be able and agree to elute prior drugs for the treatment of hemophilia.
Exclusion criteria
✕. 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;
What they're measuring
1
Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2.
Timeframe: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
✕. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
✕. 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);
✕. Ongoing or planned Immune Tolerance Induction treatment;
✕. When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
✕. Known or suspected hypersensitivity to any constituent of the trial product or related products;