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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05027230
Other study ID # STSP-0601-02
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 12, 2021
Est. completion date July 15, 2023

Study information

Verified date August 2023
Source Staidson (Beijing) Biopharmaceuticals Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date July 15, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
China Hospital of Hematology, Chinese Academy of Medical Sciences Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events From day 0 to up to day 8
Primary Proportion of successfully treated bleeding episodes 24 hours after administration of study drug
Secondary Proportion of bleeding episodes with clinical relief of signs and symptoms 4 hours?8 hours?24 hours after first administration of study drug
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