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

Hisun Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Hepatitis, Alcoholic

Treatments: Drug: Ademethionine; Drug: Polyene Phosphatidyl choline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02024295

XMX-AH-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Ademethionine

Experimental group

Description:

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

Treatment:

Drug: Ademethionine

Drug: Ademethionine

Polyene Phosphatidyl choline

Active Comparator group

Description:

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

Treatment:

Drug: Polyene Phosphatidyl choline

Drug: Ademethionine

Drug: Ademethionine