Brief Title
A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Official Title
A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Brief Summary
This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at five dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of subjects of adverse events
Secondary Outcome
Activated partial thromboplastin time
Condition
Hemophilia
Intervention
STSP-0601 for Injection
Study Arms / Comparison Groups
A single lowest dose of treatment group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
January 15, 2020
Completion Date
May 2021
Primary Completion Date
March 2021
Eligibility Criteria
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 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, or treatment for a bleeding was stopped within 7d of the time of study drug administration. - 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 drug administration.
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Lei Zhang, 13811864434, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04747964
Organization ID
STSP-0601-01
Responsible Party
Sponsor
Study Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study Sponsor
Lei Zhang, Principal Investigator, Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Verification Date
February 2021