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.

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ningning Zhang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liver Injury Group
The patients have liver injuries caused by antitumor drugs.
Take Bicyclol tablets for the treatment of liver injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in ALT level from baseline after 4 weeks treatment of bicyclol
Time Frame: 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
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Wei Lu, M.D, Tianjin Medical University Cancer Institute & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

February 2, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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