A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor (NCT05027230) | Clinical Trial Compass
CompletedPhase 1/2
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
China77 participantsStarted 2021-10-12
Plain-language summary
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
Who can participate
Age range18 Years – 65 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years old ≤age≤65 years of age,male.
* Hemophilia A or B patients with inhibitors.
* Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
* Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
* Establish proper venous access.
* Agree to use adequate contraception to avoid pregnancy.
* 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 a history of arterial and/or venous thromboembolic events.
* Have platelet \<100,000/mL,hemoglobin\<90g/L.
* Severe liver or kidney disease.
* Bleeding in the central nervous system or throat before screening.
* Accept major operation or blood transfusion within 1 month of the time of screening.
* HIV positive with current CD4+ count of less than 200/μl.
* Have a known allergy to Blood product.
* Participate in other clinical research within 1 month of the time of study drug administration.
* Treat with coagulant within 7d of the time of study drug administration.
What they're measuring
1
Incidence of adverse events
Timeframe: From day 0 to up to day 8
2
Proportion of successfully treated bleeding episodes
Timeframe: 24 hours after administration of study drug