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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Hepatitis, Alcoholic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ademethionine

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

Group Type EXPERIMENTAL

Ademethionine

Intervention Type DRUG

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

Ademethionine

Intervention Type DRUG

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

Polyene Phosphatidyl choline

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

Group Type ACTIVE_COMPARATOR

Polyene Phosphatidyl choline

Intervention Type DRUG

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

Ademethionine

Intervention Type DRUG

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

Interventions

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Ademethionine

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

Intervention Type DRUG

Polyene Phosphatidyl choline

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

Intervention Type DRUG

Ademethionine

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

Intervention Type DRUG

Other Intervention Names

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ademethionine for 6 weeks Polyene Phosphatidyl choline for 6 weeks stage 2, ademethionine for 42 weeks.

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No