Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

Study Overview
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Brief Summary
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To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

Detailed Description
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randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

Official Title
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Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

Conditions
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Hepatitis, Alcoholic

Intervention / Treatment
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* Drug: Ademethionine
* Drug: Polyene Phosphatidyl choline
* Drug: Ademethionine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index range 19-30kg/m2 Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day; STB from 2 to 10X ULN; ALP>1.5X ULN or GGT>3X ULN Exclusion Criteria: any one of below, active virus hepatitis, or anti-HIV(+) exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis other non-hepatic diseases caused jaundice primary hepatic carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ademethionine<br>ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks. | Drug: Ademethionine<br>* ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.<br>* Other names: ademethionine for 6 weeks;Drug: Ademethionine<br>* after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks<br>* Other names: stage 2, ademethionine for 42 weeks.;|
| Active Comparator: Polyene Phosphatidyl choline<br>Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks. | Drug: Polyene Phosphatidyl choline<br>* Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.<br>* Other names: Polyene Phosphatidyl choline for 6 weeks;Drug: Ademethionine<br>* after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks<br>* Other names: stage 2, ademethionine for 42 weeks.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate of serum total bilirubin | response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30% | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of serum direct bilirubin |  | 6 weeks and 48 weeks | 
| level of serum bile acids |  | 6 weeks and 48 weeks | 
| level of glutamic pyruvic transaminase |  | 6 weeks and 48 weeks | 
| level of glutamic oxaloacetic transaminase |  | 6 weeks and 48 weeks | 
| level of alkaline phosphatase |  | 6 weeks and 48 weeks | 
| level of gamma-glutamyl transpeptidase |  | 6 weeks and 48 weeks | 
| level of hyaluronic acid |  | 6 weeks and 48 weeks |