KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors (NCT06747416) | Clinical Trial Compass
Not Yet RecruitingPhase 2
KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors
24 participantsStarted 2025-09-02
Plain-language summary
The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \<1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI \<30 kg/m\^2.
✓. Severe Hemophilia A or moderate-to-severe Hemophilia B (coagulation factor FVIII activity \<1% or FIX activity ≤2%).
✓. Have ≥ 6 treated bleeding episodes within 24 weeks prior to screening (spontaneous and/or traumatic, excluding bleeding episodes related to surgery or traumatic operation).
✓. Patients without inhibitors must meet the following criteria: FVIII or FIX inhibitor test is negative during the screening period. Use coagulation factor replacement therapy for no less than 100 exposure days before screening.
✓. Patients with inhibitors must meet the following criteria: FVIII or FIX inhibitor test is positive during the screening period. Inhibitors level with high titer positive (≥5 BU/ml) or current low titer positive (\<5 BU/ml) refractory to FVIII or FIX replacement and with FVIII or FIX recovery \< 60% of expected within previous 12 months prior to screening.
Exclusion criteria
✕. Those with serious or poorly controlled chronic diseases or obvious systemic diseases: such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, neurological diseases or psychiatric diseases, bacterial or viral infection, etc.; have previously received lipid-lowering therapy for hypertriglyceridemia or are currently receiving lipid-lowering therapy for hypertriglyceridemia.
✕. Have a history of other hereditary or acquired bleeding disorders other than Hemophilia A and Hemophilia B.
✕. Have symptoms and signs related to thromboembolic disease or are receiving thrombolytic/antithrombotic treatment; have a history of coronary atherosclerotic disease, arterial or venous thrombosis, or ischemic disease of important organs.
What they're measuring
1
Incidence and severity of treatment emergent adverse events(TEAEs)
Timeframe: Week 0 up to Week 26
2
Number of participants with abnormal laboratory findings in Hematology
Timeframe: Week 0 up to Week 26
3
Number of participants with abnormal laboratory findings in Coagulation Function
Timeframe: Week 0 up to Week 26
4
Number of participants with abnormal laboratory findings in Blood Biochemistry
Timeframe: Week 0 up to Week 26
5
Number of participants with clinically significant changes in 12-lead electrocardiograms
Timeframe: Week 0 up to Week 26
6
Number of participants with clinically significant changes in vital signs
Timeframe: Week 0 up to Week 26
7
Number of participants with clinically significant changes in physical examination Findings
✕. Have high risk factors for thrombosis, including reduced activity of antithrombin III, protein S or protein C.
✕. When bleeding occurred in the past, rFVIIa was ineffective and (activated) prothrombin complex concentrate (PCC/aPCC) treatment must be used.
✕. Are undergoing or planning to undergo immune tolerance induction therapy.
✕. Regular use of immunomodulatory therapy, such as regular infusion of immune globulin or regular use of hormones, is required.
✕. Those with allergies; those who are allergic to test drugs/similar drugs or excipients; those with a history of multiple allergies (two categories or more); those with a history of specific reactions, such as being allergic to heparin or having experienced heparin-induced thrombocytopenia.