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

Phase 4

• Conditions: Hepatitis, Alcoholic
• Interventions: Drug: Ademethionine; Drug: Polyene Phosphatidyl choline

• Registration Number: NCT02024295
• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-25
• Study First Posted: 2013-12-31
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ademethionine	Ademethionine	ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Polyene Phosphatidyl choline	Ademethionine	Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Polyene Phosphatidyl choline	Polyene Phosphatidyl choline	Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.

Primary Outcome Measures

Name	Time	Method
response rate of serum total bilirubin	6 weeks	response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%

Secondary Outcome Measures

Name	Time	Method
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 gamma-glutamyl transpeptidase	6 weeks and 48 weeks
level of hyaluronic acid	6 weeks and 48 weeks
level of alkaline phosphatase	6 weeks and 48 weeks

Trial Locations

Locations (2)

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Jun Cheng; 🇨🇳 Beijing, Beijing, China