Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Study Overview
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Brief Summary
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This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

Detailed Description
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evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Official Title
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Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Conditions
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Hepatitis B, Cholestasis

Intervention / Treatment
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* Drug: Ademetionine 2
* Drug: Ademetionine 1
* Drug: Ademetionine 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: from 18-65 years old diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+) with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN Exclusion Criteria: liver mass, liver carcinoma liver failure non-hepatic diseases caused jaundice obstructive jaundice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Ademetionine 1<br>Ademetionine 2000mg | Drug: Ademetionine 1<br>* Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks<br>|
| Experimental: Ademetionine 2<br>Ademetionine 1000mg | Drug: Ademetionine 2<br>* Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks<br>|
| Active Comparator: Ademetionine 3<br>no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks | Drug: Ademetionine 3<br>* no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of serum total bilirubin declined from baseline | levels of serum total bilirubin declined from baseline | 2 weeks | 
| Alkaline Phosphatase | Alkaline Phosphatase | 10 weeks | 
| Gamma-Glutamyl Transpeptidase | Gamma-Glutamyl Transpeptidase | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of serum direct bilirubin decline from baseline | level of serum direct bilirubin decline from baseline | 2 weeks, 6 weeks, 10 weeks | 
| level of serum bile acids decline from baseline | level of serum bile acids decline from baseline | 2 weeks, 6 weeks, 10 weeks | 
| glutamic pyruvic transaminase | glutamic pyruvic transaminase | 2 weeks, 6 weeks, 10 weeks | 
| glutamic oxaloacetic transaminase | glutamic oxaloacetic transaminase | 2 weeks, 6 weeks, 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Cholestasis