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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05711459
Recruitment Status : Recruiting
First Posted : February 3, 2023
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug-Induced Acute Liver Injury Drug: Bicyclol tablets Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5405 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Liver Injury Group
The patients have liver injuries caused by antitumor drugs.
 Drug: Bicyclol tablets
Take Bicyclol tablets for the treatment of liver injury.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05711459


Contacts
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Contact: Wei Lu, M.D +86-22-23340123 ext 3089 mail4luwei@163.com
Contact: Ningning Zhang, M.D +86-18920168107 mail4ningning@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Wei Lu, M.D    +86-22-23340123 ext 3089    mail4luwei@163.com   
Contact: Ningning Zhang, M.D    +86-18920168107    mail4ningning@163.com   
Principal Investigator: Wei Lu, M.D         
Sub-Investigator: Ningning Zhang, M.D         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Chair: Wei Lu, M.D Tianjin Medical University Cancer Institute & Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT05711459    
Other Study ID Numbers: BDILI
First Posted: February 3, 2023    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Prospective Study
Multicenter Trials
Bicyclol Tablet
Antineoplastic Drug-induced Liver Injury
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Wounds and Injuries
Liver Diseases
Digestive System Diseases
 Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning