CompletedPhase 2

Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor

China25 participantsStarted 2024-03-18

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 inhibitor.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 ≤age≤70 years of age,male.
✓. Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
✓. Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
✓. Establish proper venous access.
✓. There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
✓. Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
✓. Provide signed informed consent.

Exclusion criteria

✕. Have any coagulation disorder other than hemophilia.
✕. Plan to receive prophylactic treatment of coagulation factor during the trail.
✕. Patients plan to receive Emicizumab 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.

What they're measuring

Proportion of successfully treated bleeding episodes

Timeframe: 12 hours after first administration of study drug

Trial details

NCT IDNCT06289166

SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-17

View on ClinicalTrials.gov More Hemophilia trials