NCT05711459

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,405 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-Induced Acute Liver Injury

Interventions

Type	Name	Description
DRUG	Bicyclol tablets	Take Bicyclol tablets for the treatment of liver injury.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2023-02-03
• Last updated: 2023-02-03

Locations

1 site across 1 country: China