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

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ClinicalTrials.gov Identifier: NCT02024295
Recruitment Status : Unknown
Verified May 2014 by Zhejiang Hisun Pharmaceutical Co. Ltd..
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Zhejiang Hisun Pharmaceutical Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Hepatitis, Alcoholic Drug: Ademethionine Drug: Polyene Phosphatidyl choline Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ademethionine
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Drug: Ademethionine
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Other Name: ademethionine for 6 weeks
Drug: Ademethionine
after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks
Other Name: stage 2, ademethionine for 42 weeks.
Active Comparator: Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Drug: Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Other Name: Polyene Phosphatidyl choline for 6 weeks
Drug: Ademethionine
after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks
Other Name: stage 2, ademethionine for 42 weeks.



Primary Outcome Measures :
  1. response rate of serum total bilirubin [ Time Frame: 6 weeks ]
    response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%


Secondary Outcome Measures :
  1. level of serum direct bilirubin [ Time Frame: 6 weeks and 48 weeks ]
  2. level of serum bile acids [ Time Frame: 6 weeks and 48 weeks ]
  3. level of glutamic pyruvic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  4. level of glutamic oxaloacetic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  5. level of alkaline phosphatase [ Time Frame: 6 weeks and 48 weeks ]
  6. level of gamma-glutamyl transpeptidase [ Time Frame: 6 weeks and 48 weeks ]
  7. level of hyaluronic acid [ Time Frame: 6 weeks and 48 weeks ]

Other Outcome Measures:
  1. Liver biopsy [ Time Frame: 48 weeks ]
    Liver biopsy is not demanded



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024295


Contacts
Contact: Jun Cheng 8610-84322000 jun.cheng.ditan@gmail.com

Locations
China, Beijing
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Jun Cheng    8610-84322566    jun.cheng.ditan@gmail.com   
Jun Cheng Recruiting
Beijing, Beijing, China, 100015
Contact: Jun Cheng         
Sponsors and Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
Principal Investigator: Jun Cheng Beijing Ditan Hospital affiliated ffiated to Capital Medical University

Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02024295     History of Changes
Other Study ID Numbers: XMX-AH-001
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Cholestasis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Bile Duct Diseases
Biliary Tract Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Choline
Polyene phosphatidylcholine
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents