A Phase 2 interventional study of bicyclol tablet 25mg and bicyclol tablet 50mg in Drug-Induced Acute Liver Injury, sponsored by Drug Induced Liver Disease Study Group. Completed at 17 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Drug Induced Liver Disease Study Group · Phase 2, Interventional, and Treatment
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.
Explore the safety and efficacy of different doses of bicyclol in treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.
The study adopted the design of multi center, randomized, double-blind, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and 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.
75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.
This study's enrollment of 244 is above the median of 80 across 36 interventional studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →Drug Induced Liver Disease Study Group is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.
Drug: bicyclol tablet 25mg
Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.
Drug: bicyclol tablet 50mg
Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.
Drug: polyene phosphatidylcholine capsule 456mg
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.
Also known as: bicyclol blank analog tablet, polyene phosphatidylcholine blank analog capsule
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.
Also known as: polyene phosphatidylcholine blank analog capsule
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.
Also known as: bicyclol blank analog tablet
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
Time frame: 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
The decrease value of serum AST compared to the baseline
Time frame: 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
The decrease value of serum ALT compared to the baseline
Time frame: 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
The decrease rate of serum ALT compared to the baseline
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The time from treatment to ALT normalization
The time from treatment to ALT normalization
Time frame: 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
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The area under curve of ALT and AST
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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