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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary: randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.
Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

Current Primary Outcome: 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%


Original Primary Outcome: response rate of serum total bilirubin [ Time Frame: 6 weeks ]

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


Current Secondary Outcome:

  • level of serum direct bilirubin [ Time Frame: 6 weeks and 48 weeks ]
  • level of serum bile acids [ Time Frame: 6 weeks and 48 weeks ]
  • level of glutamic pyruvic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  • level of glutamic oxaloacetic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  • level of alkaline phosphatase [ Time Frame: 6 weeks and 48 weeks ]
  • level of gamma-glutamyl transpeptidase [ Time Frame: 6 weeks and 48 weeks ]
  • level of hyaluronic acid [ Time Frame: 6 weeks and 48 weeks ]


Original Secondary Outcome:

  • level of serum direct bilirubin [ Time Frame: 6 weeks and 48 weeks ]
  • level of serum bile acids [ Time Frame: 6 weeks and 48 weeks ]
  • level of glutamic pyruvic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  • level of glutamic oxaloacetic transaminase [ Time Frame: 6 weeks and 48 weeks ]
  • level of alkaline phosphatase [ Time Frame: 6 weeks and 48 weeks ]
  • level of gamma-glutamyl transpeptidace [ Time Frame: 6 weeks and 48 weeks ]
  • level of hyaluronic acid [ Time Frame: 6 weeks and 48 weeks ]


Information By: Zhejiang Hisun Pharmaceutical Co. Ltd.

Dates:
Date Received: December 19, 2013
Date Started: December 2013
Date Completion: December 2015
Last Updated: May 28, 2014
Last Verified: May 2014