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The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI

Primary Purpose

Drug-Induced Acute Liver Injury

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
bicyclol, 25mg/ tablet
polyene phosphatidylcholine capsules, 228mg/ particle.
Sponsored by
Drug Induced Liver Disease Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-Induced Acute Liver Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18~75 years old, male or female;
  2. When screening, the threshold of serum liver biochemical test meets one of the following criteria: i: ALT≥5ULN; ii: ALP≥2ULN; iii: ALT≥3ULN, and TBiL≥2ULN;
  3. During the screening, the patients with hepatocellular injury type or mixed type DILI mainly manifested by a significant increase in ALT were mainly selected;
  4. Meeting the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3~5, the subject needs three liver disease experts to confirm whether he is DILI patient, meanwhile, at least two of three liver disease experts should have the same judgment.
  5. Liver biochemical indexes (ALT, AST, ALP, GGT, TBiL, albumin, prothrombin time) abnormalities lasted no more than 90 days;
  6. Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods, and the risk they may need to bear if they participate in the test and sign the informed consent.

Exclusion Criteria:

  1. Liver injury is caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease, etc.;
  2. Patients with acute or subacute liver failure; patients with acute liver failure or liver decompensation, such as hepatic encephalopathy, ascites, albumin is less than normal value, International normalized ratio (INR) of prothrombin time greater than 1.5;
  3. Cholestatic DILI;
  4. Serum creatinine is more than 1.5 times ULN;
  5. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
  6. Simultaneous application of drugs that affect the efficacy of this trial;
  7. Allergy or intolerance to experimental drugs;
  8. With no ability to express their complaints, such as mental illness and severe neurosis patient;
  9. The patient can not cooperate and poor compliance;
  10. Pregnant and lactating women or women preparing for pregnancy;
  11. The patient participated in other clinical trials in 3 months before entering this study;
  12. Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within last 3 days;
  13. The researchers consider not suitable.

Sites / Locations

  • Renji Hospital ,Shanghai Jiao Tong University School of MedicineRecruiting
  • 905th Hospital of Pla Navy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.

Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.

Outcomes

Primary Outcome Measures

The normalization rate of serum ALT after 4 weeks of treatment
The normalization rate of serum ALT after 4 weeks of treatment

Secondary Outcome Measures

The normalization rate of serum ALT after 2 weeks of treatment
The normalization rate of serum ALT after 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
The time from the start of treatment to the return of ALT
The time from the start of treatment to the return of ALT
The normalization rate of serum AST after 2 weeks of treatment
The normalization rate of serum AST after 2 weeks of treatment
The normalization rate of serum AST after 4 weeks of treatment
The normalization rate of serum AST after 4 weeks of treatment
The decrease in serum AST relative to baseline at 2 weeks of treatment.
The decrease in serum AST relative to baseline at 2 weeks of treatment.
The decrease in serum AST relative to baseline at 4 weeks of treatment.
The decrease in serum AST relative to baseline at 4 weeks of treatment.

Full Information

First Posted
September 9, 2021
Last Updated
August 3, 2022
Sponsor
Drug Induced Liver Disease Study Group
Collaborators
Beijing Union Pharmaceutical Factory
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1. Study Identification

Unique Protocol Identification Number
NCT05063500
Brief Title
The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI
Official Title
A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drug Induced Liver Disease Study Group
Collaborators
Beijing Union Pharmaceutical Factory

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 study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
Detailed Description
Further evaluated the safety and efficacy of bicyclol in the treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug. The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Acute Liver Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
bicyclol, 25mg/ tablet
Intervention Description
Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
polyene phosphatidylcholine capsules, 228mg/ particle.
Intervention Description
Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
Primary Outcome Measure Information:
Title
The normalization rate of serum ALT after 4 weeks of treatment
Description
The normalization rate of serum ALT after 4 weeks of treatment
Time Frame
After 4 weeks of treatment
Secondary Outcome Measure Information:
Title
The normalization rate of serum ALT after 2 weeks of treatment
Description
The normalization rate of serum ALT after 2 weeks of treatment
Time Frame
After 2 weeks of treatment
Title
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
Description
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
Time Frame
After 2 weeks of treatment
Title
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
Description
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
Time Frame
After 4 weeks of treatment
Title
The time from the start of treatment to the return of ALT
Description
The time from the start of treatment to the return of ALT
Time Frame
Up to 4 weeks
Title
The normalization rate of serum AST after 2 weeks of treatment
Description
The normalization rate of serum AST after 2 weeks of treatment
Time Frame
After 2 weeks of treatment
Title
The normalization rate of serum AST after 4 weeks of treatment
Description
The normalization rate of serum AST after 4 weeks of treatment
Time Frame
After 4 weeks of treatment
Title
The decrease in serum AST relative to baseline at 2 weeks of treatment.
Description
The decrease in serum AST relative to baseline at 2 weeks of treatment.
Time Frame
After 2 weeks of treatment
Title
The decrease in serum AST relative to baseline at 4 weeks of treatment.
Description
The decrease in serum AST relative to baseline at 4 weeks of treatment.
Time Frame
After 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18~75 years old, male or female; When screening, the threshold of serum liver biochemical test meets one of the following criteria: i: ALT≥5ULN; ii: ALP≥2ULN; iii: ALT≥3ULN, and TBiL≥2ULN; During the screening, the patients with hepatocellular injury type or mixed type DILI mainly manifested by a significant increase in ALT were mainly selected; Meeting the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3~5, the subject needs three liver disease experts to confirm whether he is DILI patient, meanwhile, at least two of three liver disease experts should have the same judgment. Liver biochemical indexes (ALT, AST, ALP, GGT, TBiL, albumin, prothrombin time) abnormalities lasted no more than 90 days; Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods, and the risk they may need to bear if they participate in the test and sign the informed consent. Exclusion Criteria: Liver injury is caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease, etc.; Patients with acute or subacute liver failure; patients with acute liver failure or liver decompensation, such as hepatic encephalopathy, ascites, albumin is less than normal value, International normalized ratio (INR) of prothrombin time greater than 1.5; Cholestatic DILI; Serum creatinine is more than 1.5 times ULN; Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases; Simultaneous application of drugs that affect the efficacy of this trial; Allergy or intolerance to experimental drugs; With no ability to express their complaints, such as mental illness and severe neurosis patient; The patient can not cooperate and poor compliance; Pregnant and lactating women or women preparing for pregnancy; The patient participated in other clinical trials in 3 months before entering this study; Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within last 3 days; The researchers consider not suitable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yimin Mao
Phone
13003175438
Email
maoym11968@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Mao
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chengwei Chen
Organizational Affiliation
905th Hospital of Pla Navy
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital ,Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yimin Mao
Phone
13003175438
Email
maoym11968@163.com
Facility Name
905th Hospital of Pla Navy
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengwei Chen
Phone
13901989118
Email
ccw2@163.com

12. IPD Sharing Statement

Learn more about this trial

The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI

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