Hemophilia
Conditions
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.
Interventions
A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | From day 0 to up to day 8 |
| Proportion of successfully treated bleeding episodes | 24 hours after administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of bleeding episodes with clinical relief of signs and symptoms | 4 hours、8 hours、24 hours after first administration of study drug |
Countries
China
Outcome results
None listed