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

NCT05063500 | Unknown Phase 3

• 1 other identifier: SHC-2020
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Drug-Induced Acute Liver Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The normalization rate of serum ALT after 2 weeks of treatment

  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 4 weeks of treatment;

  After 4 weeks of treatment

• The time from the start of treatment to the return of ALT

  Up to 4 weeks

• The normalization rate of serum AST after 2 weeks of treatment

  After 2 weeks of treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: bicyclol, 25mg/ tablet

Control group

ACTIVE COMPARATOR

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

Drug: polyene phosphatidylcholine capsules, 228mg/ particle.

Interventions

bicyclol, 25mg/ tablet DRUG

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

Experimental group

polyene phosphatidylcholine capsules, 228mg/ particle. DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drug Induced Liver Disease Study Group: lead
• Beijing Union Pharmaceutical Factory Ltd: collaborator

Study Sites (2)

Renji Hospital ，Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

905th Hospital of Pla Navy

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

bicyclol; Tablets; polyene phosphatidylcholine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yimin Mao

  RenJi Hospital

  STUDY CHAIR

• Chengwei Chen

  905th Hospital of Pla Navy

  STUDY CHAIR

Central Study Contacts

Yimin Mao

CONTACT

13003175438; maoym11968@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 1, 2021
• Study Start: December 20, 2021
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

CN (2)