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

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027230
• Other study ID #: STSP-0601-02
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

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