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

Last updated: September 12, 2024
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Overall Status: Completed

Phase

1

Condition

Hemophilia

Treatment

STSP-0601 for Injection

Clinical Study ID

NCT04747964
STSP-0601-01
  • Ages 18-65
  • Male

Study Summary

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old ≤age≤65 years of age,male.

  • Hemophilia A or B patients with inhibitors.

  • Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.

  • Establish proper venous access.

  • Provide signed informed consent.

Exclusion

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 an active, ongoing bleeding for which the patient is being treated, ortreatment for a bleeding was stopped within 7d of the time of study drugadministration.

  • Have a history of arterial and/or venous thromboembolic events.

  • Have platelet count <100,000/mL.

  • Severe liver or kidney disease.

  • Accept major operation or blood transfusion within 1 month of the time of screening.

  • HIV antibody positive.

  • Have a known allergy to Blood product.

  • Participate in other clinical research within 1 month of the time of study drugadministration.

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: STSP-0601 for Injection
Phase: 1
Study Start date:
January 15, 2020
Estimated Completion Date:
April 19, 2021

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin,
    China

    Site Not Available

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