A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Phase 1
Completed
- Conditions
- Hemophilia
- Interventions
- Drug: STSP-0601 for Injection
- Registration Number
- NCT05027230
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 77
Inclusion Criteria
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
Exclusion Criteria
- Have any coagulation disorder other than hemophilia A or B.
- Treat with prophylactic treatment of coagulation factor.
- Treat with anticoagulant within 7d of the time of study drug administration.
- Have a history of arterial and/or venous thromboembolic events.
- Have platelet <100,000/mL,hemoglobin<90g/L.
- Severe liver or kidney disease.
- Bleeding in the central nervous system or throat before screening.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV positive with current CD4+ count of less than 200/μl.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug administration.
- Treat with coagulant within 7d of the time of study drug administration.
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 Proportion of successfully treated bleeding episodes 24 hours after administration of study drug Incidence of adverse events From day 0 to up to day 8
- Secondary Outcome Measures
Name Time Method Proportion of bleeding episodes with clinical relief of signs and symptoms 4 hours、8 hours、24 hours after first administration of study drug
Trial Locations
- Locations (1)
Hospital of Hematology, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China