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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-18

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Drug-Induced Acute Liver Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low dose group

Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.

Group Type EXPERIMENTAL

bicyclol tablet 25mg

Intervention Type DRUG

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.

high dose group

Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.

Group Type EXPERIMENTAL

bicyclol tablet 50mg

Intervention Type DRUG

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.

positive drug control group

Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.

Group Type ACTIVE_COMPARATOR

polyene phosphatidylcholine capsule 456mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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bicyclol blank analog tablet polyene phosphatidylcholine blank analog capsule polyene phosphatidylcholine blank analog capsule bicyclol blank analog tablet

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yimin Mao

Role: STUDY_CHAIR

RenJi Hospital

Chengwei Chen

Role: STUDY_CHAIR

No.85 hospital of PLA

Locations

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Anhui Provincial Hospital

Hefei, Anhui, China

Site Status

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The second affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Fuzhou General Hospital of Nanjing Military Command

Fuzhou, Fujian, China

Site Status

The First affiliated Hospital of Xinxiang Medical University

Weihui, Henan, China

Site Status

Henan Infectious Diseases Hospital

Zhengzhou, Henan, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status