Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
1 other identifier
interventional
118
1 country
2
Brief Summary
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 29, 2014
May 1, 2014
2 years
December 19, 2013
May 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
response rate of serum total bilirubin
response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%
6 weeks
Secondary Outcomes (7)
level of serum direct bilirubin
6 weeks and 48 weeks
level of serum bile acids
6 weeks and 48 weeks
level of glutamic pyruvic transaminase
6 weeks and 48 weeks
level of glutamic oxaloacetic transaminase
6 weeks and 48 weeks
level of alkaline phosphatase
6 weeks and 48 weeks
- +2 more secondary outcomes
Other Outcomes (1)
Liver biopsy
48 weeks
Study Arms (2)
Ademethionine
EXPERIMENTALademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Polyene Phosphatidyl choline
ACTIVE COMPARATORPolyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Interventions
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015, China
Jun Cheng
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Cheng
Beijing Ditan Hospital affiliated ffiated to Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
December 31, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 29, 2014
Record last verified: 2014-05