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

Phase 3

• Conditions: Drug-Induced Acute Liver Injury
• Interventions: Drug: bicyclol, 25mg/ tablet; Drug: polyene phosphatidylcholine capsules, 228mg/ particle.

• Registration Number: NCT05063500
• Lead Sponsor: Drug Induced Liver Disease Study Group

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Study Start: 2021-12-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	bicyclol, 25mg/ tablet	Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
Control group	polyene phosphatidylcholine capsules, 228mg/ particle.	Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
The normalization rate of serum ALT after 4 weeks of treatment	After 4 weeks of treatment	The normalization rate of serum ALT after 4 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Renji Hospital ，Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

905th Hospital of Pla Navy; 🇨🇳 Shanghai, Shanghai, China