Clinical trial NCT05711459: Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
Official title: A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug-Induced Acute Liver Injury
Keywords: Prospective Study
Multicenter Trials
Bicyclol Tablet
Antineoplastic Drug-induced Liver Injury
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 5405
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes in ALT level from baseline after 4 weeks treatment of bicyclol
timeFrame: 4 weeks
Secondary outcomes:
measure: The changes of ALT levels compared with baseline
timeFrame: less than 4 weeks
measure: The changes of AST levels compared with baseline
timeFrame: less than 4 weeks
measure: The condition of acute liver injuries becomes the chronic liver disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wei Lu, M.D
role: STUDY_CHAIR
References:
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