Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

Официальное название

A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach

Обзор

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor

Вмешательства

• Препарат STSP-0601 for Injection
  Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors

Первичные конечные точки

• 12 hours effective hemostasis rate [Срок оценки: 12 hours after the first administration]

Вторичные конечные точки (11)

• Effective hemostasis rate at the first 12 hours bleeding visit [Срок оценки: 12 hours after the first administration]
• 12 hours excellent + good rate [Срок оценки: 12 hours after the first administration]
• The number of medication required for effective hemostasis within 12 hours [Срок оценки: 12 hours after the first administration]
• The amount of medication (U/kg) required for effective hemostasis within 12 hours [Срок оценки: 12 hours after the first administration]
• 8-hours effective hemostasis rate [Срок оценки: 8 hours after the first administration]
• 8-hours excellent + good rate [Срок оценки: 8 hours after the first administration]
• Complete + significant relief rate [Срок оценки: 4 hours, 8 hours, 12 hours, 24 hours after the first administration]
• The time to achieve complete/significant remission after the first administration [Срок оценки: From the time after the first administration until within 72 hours after the last administration]
• Rescue treatment rate [Срок оценки: Within 72 hours after the last administration]
• The time from the onset of bleeding to complete/significant relief [Срок оценки: Within 72 hours after the last administration]
• The effective hemostasis rate of the target joint [Срок оценки: From 12 hours after the first administration to 72 hours after the last administration]

Критерии участия

Критерии включения

• 12 ≤age≤70 years of age.
• Hemophilia A or B patients.
• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• Establish proper venous access.
• There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
• Agree to use adequate contraception to avoid pregnancy.
• Provide signed informed consent.

Критерии исключения

• 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 the first administration or plan to receive these drugs during the trial.
• 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 the first administration.
• Accepted major operation or blood transfusion within 4 weeks before the first administration.
• Have a known allergy to STSP-0601.
• Pregnant, lactating, or blood pregnancy test positive female subjects
• Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
• Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
• Patients not suitable for the trail according to the judgment of the investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 18 центров

• Anhui Provincial Hospital — Хэфэй
• Lanzhou University First Hospital — Lanzhou
• Nanfang Hospital, Southern Medical University — Гуанчжоу
• Shenzhen Second People's Hospital — Шэньчжэнь
• The First affiliated hospital of Guangxi Medical University — Nanning
• North China University of Science and Technology Affiliated Hospital — Tangshan
• Harbin First Hospital Hematology Tumor Research Center — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• … и ещё 10 центров

Идентификаторы

NCT: NCT06922045 · STSP-0601-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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