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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.

Conditions
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Drug-Induced Acute Liver Injury

Intervention / Treatment
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* Drug: Bicyclol tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The acute liver injury caused by anti-tumor drugs The RUCAM assessment scale ≥6 The liver injury must in the acute phase Must be treated with bicyclol tablets Must sign informed consent - Exclusion Criteria: This acute liver injury caused by non-anti-tumor drugs Pregnant women Lactating women Childbearing age women are plan to conceive
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver Injury Group<br>The patients have liver injuries caused by antitumor drugs. | Drug: Bicyclol tablets<br>* Take Bicyclol tablets for the treatment of liver injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in ALT level from baseline after 4 weeks treatment of bicyclol | Excellence: clinical symptoms and signs disappeared, serum ALT returned to normal; Improvement: clinical symptoms disappeared (improved), serum ALT decreased more than 50% of the original value; Invalid: Failure to meet the above criteria | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of ALT levels compared with baseline | ALT changes at other time points （1 week, 2 week, 3 week) compared with baseline | less than 4 weeks | 
| The changes of AST levels compared with baseline | AST changes at other time points （1 week, 2 week, 3 week) compared with baseline | less than 4 weeks | 
| The condition of acute liver injuries becomes the chronic liver disease | Proportion of patients with chronic drug-induced liver injury after 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced Liver Injury