A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
Sponsor study identifier
interventional
360
1 country
2
Study Start
December 20, 2021
Actual (reported)Primary Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2021
Actual (reported)October 1, 2021
Actual (reported)December 20, 2021
Actual (reported)May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The normalization rate of serum ALT after 4 weeks of treatment
The normalization rate of serum ALT after 4 weeks of treatment
After 4 weeks of treatment
The normalization rate of serum ALT after 2 weeks of treatment
After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
After 4 weeks of treatment
The time from the start of treatment to the return of ALT
Up to 4 weeks
The normalization rate of serum AST after 2 weeks of treatment
After 2 weeks of treatment
Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
Renji Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
905th Hospital of Pla Navy
Shanghai, Shanghai Municipality, China
Yimin Mao
RenJi Hospital
Chengwei Chen
905th Hospital of Pla Navy
First Submitted
September 9, 2021
First Posted
October 1, 2021
Study Start
December 20, 2021
Actual (reported)Primary Completion
May 2023
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 4, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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