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

PHASE2CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

August 18, 2017

Primary Completion Date

June 10, 2019

Study Completion Date

July 31, 2019

Conditions
Drug-Induced Acute Liver Injury
Interventions
DRUG

bicyclol tablet 25mg

Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.

DRUG

bicyclol tablet 50mg

Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.

DRUG

polyene phosphatidylcholine capsule 456mg

Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.

Trial Locations (17)

101149

Beijing Chest Hospital, Capital Medical University, Beijing

200127

Renji Hospital ,Shanghai Jiao Tong University School of Medicine, Shanghai

350025

Fuzhou General Hospital of Nanjing Military Command, Fuzhou

Unknown

Anhui Provincial Hospital, Hefei

Beijing Ditan Hospital, Capital Medical University, Beijing

The second affiliated Hospital of Chongqing Medical University, Chongqing

The First affiliated Hospital of Xinxiang Medical University, Weihui

Henan Infectious Diseases Hospital, Zhengzhou

Henan Provincial People's Hospital, Zhengzhou

The Second Xiangya Hospital of Central South University, Changsha

Jiangsu Province Hospital, Nanjing

No.85 hospital of PLA, Shanghai

Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine, Shanghai

Shanghai Putuo District Central Hospital, Shanghai

Tongji Hospital of Tongji University, Shanghai

Tianjin Haihe Hospital, Tianjin

Shanghai Lung Hospital, Shanghai

All Listed Sponsors
collaborator

Beijing Union Pharmaceutical Factory Ltd

INDUSTRY

lead

Drug Induced Liver Disease Study Group

OTHER

NCT02944552 - The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI | Biotech Hunter | Biotech Hunter