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

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis, Alcoholic
• Intervention / Treatment: Drug: Ademethionine; Drug: Ademethionine; Drug: Polyene Phosphatidyl choline

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Cheng; Phone Number: 8610-84322000; Email: jun.cheng.ditan@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Beijing Ditan Hospital
      • Contact: Jun Cheng; Phone Number: 8610-84322566; Email: jun.cheng.ditan@gmail.com
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Jun Cheng
      • Contact: Jun Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver biopsy	Liver biopsy is not demanded	48 weeks

Collaborators and Investigators

• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Jun Cheng, Beijing Ditan Hospital affiliated ffiated to Capital Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 25, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Biliary Tract Diseases; Bile Duct Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis; Hepatitis A; Cholestasis; Hepatitis, Alcoholic; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline; Polyene phosphatidylcholine
• Other Study ID Numbers: XMX-AH-001