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