Меню
Идёт набор NCT05743400

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

Фаза IV С лечением Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

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: Thymoglobulin 25 milligrams (mg) Injection, blood test.
Кому может быть актуально
Состояния в реестре: Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy. Базовые параметры: от 2 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation

Обзор

Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial. The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution. The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.

Вмешательства

  • Препарат Thymoglobulin 25 milligrams (mg) Injection
    Patients will receive thymoglobulin between 5 and 20 milligrams/kilograms (mg/kg) as an intravenous infusion over a period of 2 to 5 days depending on the dose and the transplant package chosen by the physician.
  • Биопрепарат blood test
    Thymoglobulin® serum levels Time frame : samples will be drawn at the following points : * 1 after each end of perfusion ; * 1 though concentration before each perfusion ; * 3 blood samples in 3 different days during the first week; * 1 weekly for 2 weeks post HSCT.

Первичные конечные точки

  • Area under the concentration-time curve (AUC) [Срок оценки: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]
Вторичные конечные точки (2)
  • Objective function value (OFV) [Срок оценки: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]
  • Coefficient of variation of AUC [Срок оценки: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]

Критерии участия

Критерии включения

  • Patient receiving Thymoglobulin therapy as part of a first HSCT
  • Age ≥ 2 years
  • Lansky or karnofsky score ≥ 50%.
  • Enrolled in a social security plan
  • Patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient to participate in the study
  • Female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion).

Критерии исключения

  • Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT
  • Patient receiving another serotherapy during conditioning (Campath®)
  • Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
  • Known hypersensitivity to Thymoglobulin®.
  • Pregnant or lactating women
  • Patient participating simultaneously in another study of an investigational drug (no exclusion period)
  • Patient under legal protection or deprived of liberty

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

Франция · 2 центра
  • Institut d'Hématologie et d'Oncologie Pédiatrique — Lyon
  • Centre Hospitalier Lyon Sud — Pierre-Bénite

Идентификаторы

NCT: NCT05743400 · 69HCL21_1186 · 2022-501594-39-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗