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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drug Induced Liver Disease Study Group
• Collaborator: Beijing Union Pharmaceutical Factory
• Treatments: Polyene phosphatidylcholine

Criteria

Inclusion Criteria:

1. 18~75 years old, male or female;

2. 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.

3. The serum ALT is between 5 and 20 times ULN

4. Liver biochemical indexes (ALT, AST, ALP, GGT, TBiL, albumin, prothrombin time) abnormalities lasted no more than 90 days;

5. 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, prothrombin time compared with normal control extended for more than 3 seconds;

3. Serum creatinine is more than 1.5 times ULN;

4. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;

5. Simultaneous application of drugs that affect the efficacy of this trial;

6. Allergy or intolerance to experimental drugs;

7. With no ability to express their complaints, such as mental illness and severe neurosis patient;

8. The patient can not cooperate and poor compliance;

9. Pregnant and lactating women or women preparing for pregnancy;

10. The patient participated in other clinical trials in 3 months before entering this study;

11. Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within last 3 days;

12. The researchers consider not suitable.