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

Hepatitis, Alcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024295
• Other study ID #: XMX-AH-001
• Status: Recruiting
• Phase: Phase 4
• First received: December 19, 2013
• Last updated: May 28, 2014
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: Jun Cheng
• Phone: 8610-84322000
• Email: jun.cheng.ditan[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Drug:
• Ademethionine
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
• Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
• Ademethionine
after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing	Beijing
China	Jun Cheng	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver biopsy	Liver biopsy is not demanded	48 weeks	Yes
Primary	response rate of serum total bilirubin	response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%	6 weeks	Yes
Secondary	level of serum direct bilirubin		6 weeks and 48 weeks	Yes
Secondary	level of serum bile acids		6 weeks and 48 weeks	Yes
Secondary	level of glutamic pyruvic transaminase		6 weeks and 48 weeks	Yes
Secondary	level of glutamic oxaloacetic transaminase		6 weeks and 48 weeks	Yes
Secondary	level of alkaline phosphatase		6 weeks and 48 weeks	Yes
Secondary	level of gamma-glutamyl transpeptidase		6 weeks and 48 weeks	Yes
Secondary	level of hyaluronic acid		6 weeks and 48 weeks	Yes