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

Drug-Induced Acute Liver Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063500
• Other study ID #: SHC-2020
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Drug Induced Liver Disease Study Group
• Contact: Yimin Mao
• Phone: 13003175438
• Email: maoym11968[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-Induced Acute Liver Injury

Intervention

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

Locations

Country	Name	City	State
China	905th Hospital of Pla Navy	Shanghai	Shanghai
China	Renji Hospital ,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Drug Induced Liver Disease Study Group	Beijing Union Pharmaceutical Factory

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The normalization rate of serum ALT after 4 weeks of treatment	The normalization rate of serum ALT after 4 weeks of treatment	After 4 weeks of treatment
Secondary	The normalization rate of serum ALT after 2 weeks of treatment	The normalization rate of serum ALT after 2 weeks of treatment	After 2 weeks of treatment
Secondary	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;	After 2 weeks of treatment
Secondary	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;	After 4 weeks of treatment
Secondary	The time from the start of treatment to the return of ALT	The time from the start of treatment to the return of ALT	Up to 4 weeks
Secondary	The normalization rate of serum AST after 2 weeks of treatment	The normalization rate of serum AST after 2 weeks of treatment	After 2 weeks of treatment
Secondary	The normalization rate of serum AST after 4 weeks of treatment	The normalization rate of serum AST after 4 weeks of treatment	After 4 weeks of treatment
Secondary	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.	After 2 weeks of treatment
Secondary	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.	After 4 weeks of treatment