Phase
Condition
Hemophilia
Treatment
STSP-0601 for Injection
Clinical Study ID
Ages 18-65 Male
Study Summary
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
Connect with a study center
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin,
ChinaSite Not Available
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