Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor (NCT05619926) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
China32 participantsStarted 2023-01-09
Plain-language summary
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion Criteria:
* 18 ≤age≤70 years of age,male;
* Hemophilia A or B patients;
* A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
* Factor VIII or IX level \<2%, inhibitor titer \< 0.6 BU;
* There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
* 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;
* Plan to receive prophylactic treatment of coagulation factor during the trail;
* 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
* Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
* Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
* Have a history of arterial and/or venous thrombotic events;
* Platelet \<100×109/L;
* Hemoglobin\<90g/L;
* Severe liver or kidney disease;
* Severe bleeding event occurred within 4 weeks before enrollment;
* Accepted major operation or blood transfusion within 4 weeks before enrollment;
* HIV positive;
* Have a known allergy to STSP-0601;
* Participate in other clinical resear…
What they're measuring
1
Incidence of adverse events
Timeframe: From day 0 to up to day 4
2
Proportion of successfully treated bleeding episodes
Timeframe: 8 hours after first administration of study drug