Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
1 other identifier
interventional
240
1 country
1
Brief Summary
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2013
1 active site
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 14, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 29, 2014
May 1, 2014
1.5 years
November 14, 2013
May 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
levels of serum total bilirubin declined from baseline
levels of serum total bilirubin declined from baseline
2 weeks
Alkaline Phosphatase
Alkaline Phosphatase
10 weeks
Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase
10 weeks
Secondary Outcomes (4)
level of serum direct bilirubin decline from baseline
2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
2 weeks, 6 weeks, 10 weeks
Study Arms (3)
Ademetionine 1
EXPERIMENTALAdemetionine 2000mg
Ademetionine 2
EXPERIMENTALAdemetionine 1000mg
Ademetionine 3
ACTIVE COMPARATORno treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Interventions
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Eligibility Criteria
You may qualify if:
- from 18-65 years old
- diagnosed as hepatitis B, previous has HBV or HBsAg(+)\>6 months, and now HBsAg or HBV DNA(+)
- with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP\>1.5ULN and GGT\>3ULN or STB\>2ULN
You may not qualify if:
- liver mass, liver carcinoma
- liver failure
- non-hepatic diseases caused jaundice
- obstructive jaundice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Health Clinical Center Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liang Chen
Public Health Clinical Center Affiliated to Fudan 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
November 14, 2013
First Posted
December 2, 2013
Study Start
November 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 29, 2014
Record last verified: 2014-05