Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
- Conditions
- Hemophilia
- Interventions
- Drug: STSP-0601 for Injection
- Registration Number
- NCT05619926
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- 18 ≤age≤70 years of age,male;
- Hemophilia A or B patients;
- A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
- Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;
- There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
- Establish proper venous access;
- Agree to use adequate contraception to avoid pregnancy;
- Provide signed informed consent.
- Have any coagulation disorder other than hemophilia;
- Plan to receive prophylactic treatment of coagulation factor during the trail;
- 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
- Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
- Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
- Have a history of arterial and/or venous thrombotic events;
- Platelet <100×109/L;
- Hemoglobin<90g/L;
- Severe liver or kidney disease;
- Severe bleeding event occurred within 4 weeks before enrollment;
- Accepted major operation or blood transfusion within 4 weeks before enrollment;
- HIV positive;
- Have a known allergy to STSP-0601;
- Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);
- Patients not suitable for the trail according to the judgment of the investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Consecutive doses of low-dose of STSP-0601 STSP-0601 for Injection - Consecutive doses of high-dose of STSP-0601 STSP-0601 for Injection -
- Primary Outcome Measures
Name Time Method Incidence of adverse events From day 0 to up to day 4 Proportion of successfully treated bleeding episodes 8 hours after first administration of study drug
- Secondary Outcome Measures
Name Time Method Proportion of successfully treated bleeding episodes 12 hours，24 hours after first administration of study drug Proportion of bleeding episodes received salvage treatment Within 3 months after enrollment
Trial Locations
- Locations (12)
Xi'an Central Hospital
🇨🇳Xi'an, Shanxi, China
Lanzhou University First Hospita
🇨🇳Lanzhou, Gansu, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
North China University of Technology Affiliated Hospital
🇨🇳Tangshan, Hebei, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Nanjing Gulou Hospital
🇨🇳Nanjing, Jiangsu, China
Hospital of Hematology, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China