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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2023-07-29

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.

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Detailed Description

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Conditions

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Hemophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Consecutive doses of low-dose of STSP-0601

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia

Consecutive doses of high-dose of STSP-0601

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia

Interventions

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STSP-0601 for Injection

A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia

Intervention Type DRUG

STSP-0601 for Injection

A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No