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

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ClinicalTrials.gov Identifier: NCT02944552
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Beijing Union Pharmaceutical Factory
Information provided by (Responsible Party):
Drug Induced Liver Disease Study Group

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.

Condition or disease Intervention/treatment Phase
Drug-Induced Acute Liver Injury Drug: bicyclol tablet 25mg Drug: bicyclol tablet 50mg Drug: polyene phosphatidylcholine capsule 456mg Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Multi Center, Randomized, Double-blind, Positive Controlled Phase II Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Lecithin

Arm Intervention/treatment
Experimental: low dose group
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 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.
Other Names:
  • bicyclol blank analog tablet
  • polyene phosphatidylcholine blank analog capsule

Experimental: high dose group
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 high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
Other Name: polyene phosphatidylcholine blank analog capsule

Active Comparator: positive drug control group
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 positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
Other Name: bicyclol blank analog tablet




Primary Outcome Measures :
  1. The decline range of serum ALT after 4 weeks of treatment [ Time Frame: after 4 weeks of treatment ]
    The decrease value of serum ALT after 4 weeks of treatment compared to the baseline


Secondary Outcome Measures :
  1. 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 [ Time Frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks ]
    The decrease value of serum AST compared to the baseline

  2. 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 [ Time Frame: after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks ]
    The decrease value of serum ALT compared to the baseline

  3. 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 [ Time Frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks ]
    The decrease rate of serum ALT compared to the baseline

  4. The time from treatment to ALT normalization [ Time Frame: treatment period ]
    The time from treatment to ALT normalization

  5. 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 [ Time Frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks ]
    The ratio of subjects whose ALT and AST declined more than 50% compared to the base line

  6. The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks [ Time Frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks ]
    The serum ALT and AST normalization rate

  7. The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks [ 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 18-75 years old, male or female;
  2. 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;
  3. The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
  4. Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less than 90 days;
  5. 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.

Exclusion criteria:

  1. Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
  2. 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;
  3. Serum creatinine is more than 1.5 times ULN;
  4. Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
  5. Taking drugs that may affect observation of curative effect of the experimental drug during the study;
  6. Allergy or intolerance to experimental drugs;
  7. With no ability to express their complaints, such as mental illness and severe neurosis patient;
  8. The patient can not cooperate and poor compliance;
  9. Pregnant and lactating women or women preparing for pregnancy;
  10. The patient participated in other clinical trials in 3 months before entering this study;
  11. Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within three days;
  12. The researchers believe not suitable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944552


Contacts
Contact: Yimin Mao 13003175438 maoym11968@163.com

Locations
China, Beijing
Beijing Chest Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 101149
Contact: Naihui Chu         
China, Fujian
Fuzhou General Hospital of Nanjing Military Command Recruiting
Fuzhou, Fujian, China, 350025
Contact: Dongliang Li         
China, Shanghai
Renji Hospital ,Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yimin Mao    13003175438    maoym11968@163.com   
No.85 hospital of PLA Recruiting
Shanghai, Shanghai, China
Contact: Chengwei Chen    13901989118    ccw2@163.com   
Sponsors and Collaborators
Drug Induced Liver Disease Study Group
Beijing Union Pharmaceutical Factory
Investigators
Study Chair: Yimin Mao RenJi Hospital
Study Chair: Chengwei Chen No.85 hospital of PLA

Responsible Party: Drug Induced Liver Disease Study Group
ClinicalTrials.gov Identifier: NCT02944552     History of Changes
Other Study ID Numbers: YL-SHC-2015
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Chemically-Induced Disorders
Poisoning
Polyene phosphatidylcholine
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents