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

Phase 4UnknownNCT02024295

Zhejiang Hisun Pharmaceutical Co. Ltd.118 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Hepatitis, Alcoholic

Interventions

AdemethionineDRUG

ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.

Polyene Phosphatidyl cholineDRUG

Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.

AdemethionineDRUG

after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Jun Cheng

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

response rate of serum total bilirubin

response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%

Time frame: 6 weeks