Status:
COMPLETED
A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions:
Hemophilia
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04747964
Start Date
January 15 2020
End Date
April 19 2021
Last Update
September 19 2024
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China