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

Not Applicable

Recruiting

• Conditions: Drug-Induced Acute Liver Injury
• Interventions: Drug: Bicyclol tablets

• Registration Number: NCT05711459
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-11-13
• Status Verified: 2022-12
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5405

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver Injury Group	Bicyclol tablets	The patients have liver injuries caused by antitumor drugs.

Primary Outcome Measures

Name	Time	Method
The changes in ALT level from baseline after 4 weeks treatment of bicyclol	4 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China