NCT02944552|CompletedPhase 2
Loading search results
Sponsor study identifier
interventional
244
1 country
17
Study Start
August 18, 2017
Actual (reported)Primary Completion
June 10, 2019
Actual (reported)Study Completion
July 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2016
Actual (reported)October 26, 2016
Actual (reported)August 18, 2017
Actual (reported)June 10, 2019
Actual (reported)July 31, 2019
Actual (reported)The decline range of serum ALT after 4 weeks of treatment
The decrease value of serum ALT after 4 weeks of treatment compared to the baseline
after 4 weeks of treatment
The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks
after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The time from treatment to ALT normalization
treatment period
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.
Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.
Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.
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.
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.
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025, China
The First affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
Henan Infectious Diseases Hospital
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.
Yimin Mao
RenJi Hospital
Chengwei Chen
No.85 hospital of PLA
244 participants (actual enrollment reported by the registry).
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
August 18, 2017
Actual (reported)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.
Contact the study team to confirm eligibility.
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Renji Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
No.85 hospital of PLA
Shanghai, Shanghai Municipality, China
Ruijin Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Tianjin Haihe Hospital
Tianjin, Tianjin Municipality, China
Shanghai Lung Hospital
Shanghai, China
Primary Completion
June 10, 2019
Actual (reported)Study Completion
July 31, 2019
Actual (reported)Last Updated
April 28, 2020
Record last verified: 2020-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: