The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI
1 other identifier
interventional
244
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
August 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedApril 28, 2020
April 1, 2020
1.8 years
October 24, 2016
April 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
low dose group
EXPERIMENTALPatients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.
high dose group
EXPERIMENTALPatients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.
positive drug control group
ACTIVE COMPARATORPatients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- years old, male or female;
- Meet the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3-5,the subject needs three liver disease experts to confirm whether he is DILI patient, at least two of three liver disease experts should have the same judgment;
- The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
- Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less than 90 days;
- Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods and the risk they may need to bear if they participate in the test, and sign the informed consent.
You may not qualify if:
- Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
- Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, ascites, albumin is less than or equal to 35g / L, The international standardized ratio (INR) of thrombin is more than 1.5;
- Serum creatinine is more than 1.5 times ULN;
- Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
- Taking drugs that may affect observation of curative effect of the experimental drug during the study;
- Allergy or intolerance to experimental drugs;
- With no ability to express their complaints, such as mental illness and severe neurosis patient;
- The patient can not cooperate and poor compliance;
- Pregnant and lactating women or women preparing for pregnancy;
- The patient participated in other clinical trials in 3 months before entering this study;
- Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within three days;
- The researchers believe not suitable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
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
Related Publications (1)
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.
PMID: 35567757DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yimin Mao
RenJi Hospital
- STUDY CHAIR
Chengwei Chen
No.85 hospital of PLA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
August 18, 2017
Primary Completion
June 10, 2019
Study Completion
July 31, 2019
Last Updated
April 28, 2020
Record last verified: 2020-04