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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02024295

Enrollment

118

Registered

2013-12-31

Start date

2013-12-31

Completion date

2015-12-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Alcoholic

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.

Interventions

DRUGAdemethionine

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

DRUGPolyene Phosphatidyl choline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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 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
level of glutamic oxaloacetic transaminase	6 weeks and 48 weeks

Other

Measure	Time frame	Description
Liver biopsy	48 weeks	Liver biopsy is not demanded

Countries

China

Contacts

Primary ContactJun Cheng

jun.cheng.ditan@gmail.com8610-84322000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026