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

Primary Purpose

Hepatitis, Alcoholic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ademethionine
Polyene Phosphatidyl choline
Ademethionine
Sponsored by
Zhejiang Hisun Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis, Alcoholic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Ditan HospitalRecruiting
  • Jun ChengRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ademethionine

Polyene Phosphatidyl choline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

level of serum direct bilirubin
level of serum bile acids
level of glutamic pyruvic transaminase
level of glutamic oxaloacetic transaminase
level of alkaline phosphatase
level of gamma-glutamyl transpeptidase
level of hyaluronic acid

Full Information

First Posted
December 19, 2013
Last Updated
May 28, 2014
Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02024295
Brief Title
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Official Title
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Alcoholic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ademethionine
Arm Type
Experimental
Arm Description
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Arm Title
Polyene Phosphatidyl choline
Arm Type
Active Comparator
Arm Description
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ademethionine
Other Intervention Name(s)
ademethionine for 6 weeks
Intervention Description
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Polyene Phosphatidyl choline
Other Intervention Name(s)
Polyene Phosphatidyl choline for 6 weeks
Intervention Description
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ademethionine
Other Intervention Name(s)
stage 2, ademethionine for 42 weeks.
Intervention Description
after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks
Primary Outcome Measure Information:
Title
response rate of serum total bilirubin
Description
response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
level of serum direct bilirubin
Time Frame
6 weeks and 48 weeks
Title
level of serum bile acids
Time Frame
6 weeks and 48 weeks
Title
level of glutamic pyruvic transaminase
Time Frame
6 weeks and 48 weeks
Title
level of glutamic oxaloacetic transaminase
Time Frame
6 weeks and 48 weeks
Title
level of alkaline phosphatase
Time Frame
6 weeks and 48 weeks
Title
level of gamma-glutamyl transpeptidase
Time Frame
6 weeks and 48 weeks
Title
level of hyaluronic acid
Time Frame
6 weeks and 48 weeks
Other Pre-specified Outcome Measures:
Title
Liver biopsy
Description
Liver biopsy is not demanded
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Cheng
Phone
8610-84322000
Email
jun.cheng.ditan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Cheng
Organizational Affiliation
Beijing Ditan Hospital affiliated ffiated to Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Cheng
Phone
8610-84322566
Email
jun.cheng.ditan@gmail.com
Facility Name
Jun Cheng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Cheng

12. IPD Sharing Statement

Learn more about this trial

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

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