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

NCT ID: NCT05063500

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2023-06-30

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.

Conditions

Drug-Induced Acute Liver Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

bicyclol, 25mg/ tablet

Intervention Type: DRUG

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

Control group

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

Group Type: ACTIVE_COMPARATOR

polyene phosphatidylcholine capsules, 228mg/ particle.

Intervention Type: DRUG

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

Interventions

bicyclol, 25mg/ tablet

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

Intervention Type: DRUG

polyene phosphatidylcholine capsules, 228mg/ particle.

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Union Pharmaceutical Factory Ltd

INDUSTRY

Sponsor Role: collaborator

Drug Induced Liver Disease Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yimin Mao

Role: STUDY_CHAIR

RenJi Hospital

Chengwei Chen

Role: STUDY_CHAIR

905th Hospital of Pla Navy

Locations

Renji Hospital ，Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

905th Hospital of Pla Navy

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yimin Mao

Role: CONTACT

maoym11968@163.com

13003175438

Facility Contacts

Yimin Mao

Role: primary

maoym11968@163.com

13003175438

Chengwei Chen

Role: primary

ccw2@163.com

13901989118

Other Identifiers

SHC-2020

Identifier Type: -

Identifier Source: org_study_id