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Идёт набор NCT04890041

TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years

Без фазы С лечением Primary Immune Thrombocytopenic Purpura

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: TPO-RA.
Кому может быть актуально
Состояния в реестре: Primary Immune Thrombocytopenic Purpura. Базовые параметры: от 14 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

Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study

Обзор

This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .

Подробное описание

The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.

100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.

Вмешательства

  • Препарат TPO-RA
    The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.

Первичные конечные точки

  • Treatment response [Срок оценки: From the start of study treatment (Day 1) up to the end of week 6]
Вторичные конечные точки (5)
  • Treatment response [Срок оценки: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.]
  • Treatment response [Срок оценки: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.]
  • Duration of response [Срок оценки: From the start of study treatment (Day 1) up to the end of week 6]
  • Concomitant medication [Срок оценки: From the start of study treatment (Day 1) up to the end of week 6]
  • Adverse events [Срок оценки: From the start of study treatment (Day 1) up to the end of week 6]

Критерии участия

Критерии включения

  • Men and women greater than or equal to 14 years of age.
  • Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10\^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
  • Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
  • Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.

Критерии исключения

  • Patients diagnosed with secondary immune thrombocytopenia.
  • A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
  • Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
  • Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
  • Have used rituximab in the past 3 months;
  • Splenectomy in recent 3 months;
  • Those who are not considered suitable for this study by the researcher;
  • Women who are pregnant or who intend to become pregnant in the near future are excluded.

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 · 1 центр
  • Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT04890041 · IIT2020033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗