Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
Condition(s) studied
Investigational drug(s) / intervention(s)
KN057: KN057 will be administered subcutaneously once a week.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Incidence of TEAE. — Up to 12/26/56 weeks.
TEAE refers to 'treatment emergent adverse event'. - Incidence of TEAE related to the experimental drug. — Up to 12/26/56 weeks.
- Incidence of SAE. — Up to 12/26/56 weeks.
SAE refers to 'serious adverse event'. - Incidence of thromboembolic events. — Up to 12/26/56 weeks.
- Incidence of TMA and DIC. — Up to 12/26/56 weeks.
TMA refers to 'thrombotic microangiopathy'. DIC refers to 'disseminated intravascular coagulation'. - Incidence of hypersensitivity type reactions. — Up 12/26/56 weeks.
- Incidence of injection site reactions. — Up to 12/26/56 weeks.
- Incidence of clinically significant laboratory value abnormalities. — Up to 12/26/56 weeks.
- Number of participants with clinically significant changes from baseline in electrocardiograms. — Up to 12/26/56 weeks.
- Number of participants with clinically significant changes from baseline in vital signs. — Up to 12/26/56 weeks.
- Number of participants with clinically significant changes from baseline in physical exam. — Up to 12/26/56 weeks.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Recruiting |
More Suzhou Alphamab Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07545395 on ClinicalTrials.gov ↗ ← All trials in China