A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
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
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.
Number of subjects of adverse events
Activated partial thromboplastin time
STSP-0601 for Injection
Study Arms / Comparison Groups
A single lowest dose of treatment group
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 15, 2020
Primary Completion Date
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.
18 Years - 65 Years
Accepts Healthy Volunteers
Lei Zhang, 13811864434, [email protected]
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Lei Zhang, Principal Investigator, Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences