Trial record 3 of 37 for:    "Hepatitis, Alcoholic"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT02024295
First received: December 19, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Hepatitis, Alcoholic
Drug: Ademethionine
Drug: Polyene Phosphatidyl choline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

Resource links provided by NLM:


Further study details as provided by Zhejiang Hisun Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • response rate of serum total bilirubin [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%


Secondary Outcome Measures:
  • level of serum direct bilirubin [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of serum bile acids [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of glutamic pyruvic transaminase [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of glutamic oxaloacetic transaminase [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of alkaline phosphatase [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of gamma-glutamyl transpeptidase [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]
  • level of hyaluronic acid [ Time Frame: 6 weeks and 48 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Liver biopsy [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Liver biopsy is not demanded


Estimated Enrollment: 118
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02024295     History of Changes
Other Study ID Numbers: XMX-AH-001
Study First Received: December 19, 2013
Last Updated: May 28, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Cholestasis
Hepatitis
Hepatitis A
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
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
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014