The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Официальное название

The Combination of Oral Upadacitinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial

Обзор

Randomized, open-label, multicenter study to compare the efficacy and safety of Upadacitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Подробное описание

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of adults ITP patients in China. Patients were randomized to Upadacitinib + high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Вмешательства

• Препарат Dexamethasone
  Dexamethasone, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)
• Препарат Upadacitinib
  Upadacitinib 15mg qd for 12 weeks

Первичные конечные точки

• Sustained response [Срок оценки: 6 month]

Вторичные конечные точки (8)

• complete response (CR) [Срок оценки: day 14]
• Response (R) [Срок оценки: day 14]
• Number of patients with bleeding [Срок оценки: 6 month]
• Number of patients with adverse events [Срок оценки: 6 month]
• Time to response [Срок оценки: 6 month]
• Duration of response (DOR) [Срок оценки: 6 month]
• Loss of response [Срок оценки: 6 month]
• Health related quality of life [Срок оценки: 6 month]

Критерии участия

Критерии включения

• Confirmed newly-diagnosed, treatment-naive ITP;
• Platelet counts <30×109/L ;
• Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
• Willing and able to sign written informed consent.

Критерии исключения

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
• Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
• Current HIV infection or hepatitis B virus or hepatitis C virus infections;
• Active infection;
• Maligancy;
• Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
• Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
• Patients who are deemed unsuitable for the study by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07064889 · ITP-UPA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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