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Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.

Recruiting
years of age
Both
Phase N/A

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Overview

The clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome.

Description

This study prospectively studied the treatment of acute drug-induced liver injury related to anti-tumor with bicyclol tablets, to provide medical evidence in clinical practice of bicyclol treating acute drug-induced liver injury. The main purpose of this study is to evaluate the clinical efficacy and outcome of bicyclol tablets in the treatment of drug-induced liver injury and analyze the bicyclol tablet's therapeutic effects in different groups including conventional chemotherapy drugs, targeted drugs, and immunosuppressants. The secondary purpose of this study is to analyze the factors influencing the prognosis and outcome of bicyclol tablets in the treatment of acute DILI.

Eligibility

Inclusion Criteria:

  1. The acute liver injury caused by anti-tumor drugs
  2. The RUCAM assessment scale ≥6
  3. The liver injury must in the acute phase
  4. Must be treated with bicyclol tablets
  5. Must sign informed consent -

Exclusion Criteria:

  1. This acute liver injury caused by non-anti-tumor drugs
  2. Pregnant women
  3. Lactating women
  4. Childbearing age women are plan to conceive

Study details

Drug-Induced Acute Liver Injury

NCT05711459

Tianjin Medical University Cancer Institute and Hospital

25 January 2024

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