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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Treatments: Choline; Polyene phosphatidylcholine

Criteria

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