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

Drug Induced Liver Disease Study Group

Status and phase: Enrolling; Phase 3

Conditions: Drug-Induced Acute Liver Injury

Treatments: Drug: polyene phosphatidylcholine capsules, 228mg/ particle.; Drug: bicyclol, 25mg/ tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05063500

SHC-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

360 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: bicyclol, 25mg/ tablet

Control group

Active Comparator group

Description:

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

Treatment:

Drug: polyene phosphatidylcholine capsules, 228mg/ particle.