NCT05063500

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

A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Drug Induced Liver Disease Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-Induced Acute Liver Injury

Interventions

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

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2021-10-01
• Last updated: 2022-08-04

Locations

2 sites across 1 country: China