Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
Launched by SUZHOU ALPHAMAB CO., LTD. · Aug 21, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called KN057 to see if it can help prevent bleeding episodes in men with hemophilia A or B who do not have inhibitors. In this study, participants will either receive KN057 right away or switch from their current treatment to KN057 after a certain period. The trial is looking for men aged 12 to 70 who have severe or moderately severe hemophilia and have had a good track record of using their regular hemophilia treatments.
If you or someone you know is eligible, they can expect to participate for about a year, with different groups receiving different treatments during that time. The study will carefully monitor participants to ensure their safety and to see how well KN057 works in preventing bleeds. It's important to note that participants cannot have any serious health issues or previous treatments that could interfere with the trial. Overall, this study aims to find a safe and effective way to help manage hemophilia without the complications that can come from inhibitors.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 1. 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;
- • 2. Severe and moderately severe hemophilia A or hemophilia B (FVIII or FIX activity level ≤2%);
- • 3. 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;
- • 4. 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);
- • 5. Use coagulation factor replacement therapy for no less than 100 exposure days before screening;
- • 6. Have not used Anti-TFPI drugs before;
- • 7. Be able and agree to elute the original hemophilia drugs.
- Participants who are enrolled into Part A must also meet the following criteria:
- • 1. ≥6 treated bleeding episodes within 26 weeks before screening;
- • 2. 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 Criteria:
- • 1. Have serious or poorly controlled chronic diseases or obvious systemic diseases;
- • 2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
- • 3. 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;
- • 4. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
- • 5. Known or suspected hypersensitivity to any constituent of the trial product or related products;
- • 6. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study;
- • 7. Used Emicizumab treatment within 6 months before screening;
- • 8. Have received any gene therapy for hemophilia in the past;
- • 9. 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.
About Suzhou Alphamab Co., Ltd.
Suzhou Alphamab Co., Ltd. is a leading biopharmaceutical company focused on the research, development, and commercialization of innovative therapeutic solutions, particularly in the fields of oncology and autoimmune diseases. Established with a commitment to advancing healthcare, Alphamab leverages cutting-edge technologies, including monoclonal antibodies and novel drug delivery systems, to create targeted therapies that address unmet medical needs. With a robust pipeline of clinical trials and a dedication to scientific excellence, the company aims to enhance patient outcomes and contribute to the global biotechnology landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tianjin, Tianjin, China
Patients applied
Trial Officials
Renchi Yang, Doctor
Principal Investigator
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Jing Sun, Doctor
Principal Investigator
Nanfang Hospital, Southern Medical University
Hu Zhou, Doctor
Principal Investigator
Henan Cancer Hospital
Changcheng Zheng, Doctor
Principal Investigator
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Xielan Zhao, Doctor
Principal Investigator
Xiangya Hospital of Central South University
Lili Chen, Doctor
Principal Investigator
Tai Zhou First People's Hospital
Chenghao Jin, Doctor
Principal Investigator
Jiangxi Provincial People's Hopital
Yanping Song, Doctor
Principal Investigator
Xi'an Central Hospital
Yaming Xi, Doctor
Principal Investigator
LanZhou University
Zeping Zhou, Doctor
Principal Investigator
The Second Affiliated Hospital of Kunming Medical University
Runhui Wu, Doctor
Principal Investigator
Beijing Children's Hospital
Zhenyu Yan, Doctor
Principal Investigator
North China University of Science and Technology Affiliated Hospital
Sujun Gao, Doctor
Principal Investigator
The First Hospital of Jilin University
Wei Yang, Doctor
Principal Investigator
Shengjing Hospital of China University
Rong Zhou, Doctor
Principal Investigator
The Third People's Hospital of Chengdu
Ziqiang Yu, Doctor
Principal Investigator
The First Affiliated Hospital of Soochow University
Yun Chen, Doctor
Principal Investigator
Qianfoshan Hospital
Pingchong Lei, Doctor
Principal Investigator
Henan Provincial People's Hospital
Yinsuo Zheng, Doctor
Principal Investigator
Bao Ji Central Hospital
Peng Cheng, Doctor
Principal Investigator
First Affiliated Hospital of Guangxi Medical University
Jianwen Xiao, Doctor
Principal Investigator
Children's Hospital of Chongqing Medical University
Ruibin Huang, Doctor
Principal Investigator
The First Affiliated Hospital of Nanchang University
Hailiang Li, Doctor
Principal Investigator
The first affiliated hospital of jiangxi medical college
Shu Chen, Doctor
Principal Investigator
The Second Affiliated Hospital of Chongqing Medical University
Xiong Zhang, Doctor
Principal Investigator
Maoming City People's Hospital
Jingyu Zhang, Doctor
Principal Investigator
The Second Hospital of Hebei Medical Hospital
Baolai Hua, Doctor
Principal Investigator
Beijing Shijitan Hospital, Capital Medical University
Yanming Zhang, Doctor
Principal Investigator
Huai'an Second People'Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported