A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia

Conditions
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Hemophilia

Intervention / Treatment
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* Drug: STSP-0601 for Injection
* Drug: STSP-0601 for Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consecutive doses of low-dose of STSP-0601<br> | Drug: STSP-0601 for Injection<br>* A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia<br>|
| Experimental: Consecutive doses of high-dose of STSP-0601<br> | Drug: STSP-0601 for Injection<br>* A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |