Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
Primary Purpose
Drug-Induced Acute Liver Injury
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bicyclol tablets
Sponsored by
About this trial
This is an interventional treatment trial for Drug-Induced Acute Liver Injury focused on measuring Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced Liver Injury
Eligibility Criteria
Inclusion Criteria: The acute liver injury caused by anti-tumor drugs The RUCAM assessment scale ≥6 The liver injury must in the acute phase Must be treated with bicyclol tablets Must sign informed consent - Exclusion Criteria: This acute liver injury caused by non-anti-tumor drugs Pregnant women Lactating women Childbearing age women are plan to conceive
Sites / Locations
- Tianjin Medical University Cancer Institute & HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liver Injury Group
Arm Description
The patients have liver injuries caused by antitumor drugs.
Outcomes
Primary Outcome Measures
The 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
Secondary Outcome Measures
The changes of ALT levels compared with baseline
ALT changes at other time points (1 week, 2 week, 3 week) compared with baseline
The changes of AST levels compared with baseline
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
Proportion of patients with chronic drug-induced liver injury after 6 months
Full Information
NCT ID
NCT05711459
First Posted
November 13, 2022
Last Updated
February 2, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05711459
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Acute Liver Injury
Keywords
Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced Liver Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5405 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liver Injury Group
Arm Type
Experimental
Arm Description
The patients have liver injuries caused by antitumor drugs.
Intervention Type
Drug
Intervention Name(s)
Bicyclol tablets
Intervention Description
Take Bicyclol tablets for the treatment of liver injury.
Primary Outcome Measure Information:
Title
The changes in ALT level from baseline after 4 weeks treatment of bicyclol
Description
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
Secondary Outcome Measure Information:
Title
The changes of ALT levels compared with baseline
Description
ALT changes at other time points (1 week, 2 week, 3 week) compared with baseline
Time Frame
less than 4 weeks
Title
The changes of AST levels compared with baseline
Description
AST changes at other time points (1 week, 2 week, 3 week) compared with baseline
Time Frame
less than 4 weeks
Title
The condition of acute liver injuries becomes the chronic liver disease
Description
Proportion of patients with chronic drug-induced liver injury after 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The acute liver injury caused by anti-tumor drugs
The RUCAM assessment scale ≥6
The liver injury must in the acute phase
Must be treated with bicyclol tablets
Must sign informed consent -
Exclusion Criteria:
This acute liver injury caused by non-anti-tumor drugs
Pregnant women
Lactating women
Childbearing age women are plan to conceive
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Lu, M.D
Phone
+86-22-23340123
Ext
3089
Email
mail4luwei@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ningning Zhang, M.D
Phone
+86-18920168107
Email
mail4ningning@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Lu, M.D
Organizational Affiliation
Tianjin Medical University Cancer Institute & Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Lu, M.D
Phone
+86-22-23340123
Ext
3089
Email
mail4luwei@163.com
First Name & Middle Initial & Last Name & Degree
Ningning Zhang, M.D
Phone
+86-18920168107
Email
mail4ningning@163.com
First Name & Middle Initial & Last Name & Degree
Wei Lu, M.D
First Name & Middle Initial & Last Name & Degree
Ningning Zhang, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.
Citations:
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Citation
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Citation
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Links:
URL
https://gut.bmj.com/content/66/6/1154
Description
PMID: 28341748
URL
https://linkinghub.elsevier.com/retrieve/pii/S0016508513002175
Description
PMID: 23419359
URL
https://linkinghub.elsevier.com/retrieve/pii/S001650851500311X
Description
PMID: 25754159
URL
https://linkinghub.elsevier.com/retrieve/pii/0895435693901016
Description
PMID: 8229110
URL
https://www.degruyter.com/document/doi/10.1515/med-2018-0010/html
Description
PMID: 29607414
URL
https://medscimonit.com/abstract/index/idArt/904090
Description
PMID: 29200411
Learn more about this trial
Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
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