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

Phase 2 Completed 244 enrolled Drug Induced Liver Disease Study Group Beijing Union Pharmaceutical Factory Ltd · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

Timeline

Start: 2017-08-18
Primary completion: 2019-06-10
Completion: 2019-07-31

Outcome

Met primary endpoint

paper ALT levels decreased across groups (-249.2 ± 151.1, -273.6 ± 203.1, and -180.8 ± 218.2 U/L in the low-dose bicyclol, high-dose bicyclol and control groups, respectively; PMID 35567757 ↗

paper both p < .001, the bicyclol-dependent groups vs. control group). PMID 35567757 ↗

Publications

Tang J, Gu J, Chu N, Chen Y, Wang Y, Xue D, Xie Q, Li L, Mei Z, Wang X, Li J, Chen J, Li Y, Yang C, Wang Y, Shang J, Xie W, Hu P, Li D, Zhao L, Lan P, Wang C, Chen C, Mao Y. Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial. Liver Int. 2022 Aug;42(8):1803-1813. doi: 10.1111/liv.15290. Epub 2022 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Polyene Phosphatidylcholine	Small molecule	456 mg	—
Subject	bicyclol	Small molecule	25 mg	Oral
Subject	bicyclol	Small molecule	50 mg	Oral