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

Tianjin Medical University

Status: Enrolling

Conditions: Drug-Induced Acute Liver Injury

Treatments: Drug: Bicyclol tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05711459

BDILI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,405 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,405 participants in 1 patient group

Liver Injury Group

Experimental group

Description:

The patients have liver injuries caused by antitumor drugs.

Treatment:

Drug: Bicyclol tablets