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Набор по приглашению NCT06698211

Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

— Наблюдательное Invasive Fungal Disease Graft Versus Host Disease Hematopoietic Stem Cell Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Posaconazole tablet.
Кому может быть актуально
Состояния в реестре: Invasive Fungal Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Evaluation of Posaconazole Tablet As Primary Prophylaxis of Hematopoietic Stem Cell Transplant Patients with Gastrointestinal GVHD

Обзор

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.

Подробное описание

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection

Вмешательства

  • Препарат Posaconazole tablet
    Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to

Первичные конечные точки

  • primary endpoint [Срок оценки: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis]
Вторичные конечные точки (3)
  • 2 [Срок оценки: Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD]
  • 3 [Срок оценки: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.]
  • 4 [Срок оценки: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.]

Критерии участия

Критерии включения

  • Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
  • Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
  • Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.

Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.

  • Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent

Критерии исключения

  • refuse to enroll
  • patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
  • pregnant or lactating females
  • take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before Posaconazole application; astemizole at enrollment or within 10 days before Posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before Posaconazole application
  • have an ECG with a prolonged QTc interval (QTc greater than 500 ms);
  • have severe renal insufficiency, alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin levels more than two-times the upper limit of normal;
  • patients are expected to survive no more than 72 h;
  • Those with evidence of active fungal infection within 3 weeks prior to enrollment

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & P — Тяньцзинь

Идентификаторы

NCT: NCT06698211 · QTJC2024039

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗