Trial | NCT01998620  Report issue

Official Title

Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    240
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.
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
Study Started
Nov 30
2013
Primary Completion
May 31
2015
Anticipated
Study Completion
May 31
2015
Anticipated
Last Update
May 29
2014
Estimate

Drug Ademetionine 2

Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks

Drug Ademetionine 1

Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Drug Ademetionine 3

no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Ademetionine 1 Experimental

Ademetionine 2000mg

Ademetionine 2 Experimental

Ademetionine 1000mg

Ademetionine 3 Active Comparator

no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

liver mass, liver carcinoma
liver failure
non-hepatic diseases caused jaundice
obstructive jaundice
No Results Posted