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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5,405
Take Bicyclol tablets for the treatment of liver injury.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe 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
Time frame: 4 weeks
The changes of ALT levels compared with baseline
ALT changes at other time points （1 week, 2 week, 3 week) compared with baseline
Time frame: 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
Time frame: 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
Time frame: 6 months
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