Drug-Induced Acute Liver Injury
Conditions
Keywords
Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced Liver Injury
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.
Interventions
DRUGBicyclol tablets
Take Bicyclol tablets for the treatment of liver injury.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
China
Contacts
Primary ContactWei Lu, M.D
Backup ContactNingning Zhang, M.D
Outcome results
None listed