Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial

Background and Aims Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI. Methods This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks. Results Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. 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; both p