Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
from 18-65 years old
with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
from 18-65 years old
with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criterias

non-hepatic diseases caused jaundice
liver failure
obstructive jaundice
...
non-hepatic diseases caused jaundice
liver failure
obstructive jaundice
liver mass, liver carcinoma

Summary

Conditions
  • Cholestasis
  • Hepatitis B
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Inclusion Criterias

diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
from 18-65 years old
with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
from 18-65 years old
with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criterias

non-hepatic diseases caused jaundice
liver failure
obstructive jaundice
...
non-hepatic diseases caused jaundice
liver failure
obstructive jaundice
liver mass, liver carcinoma

Locations

Shanghai, Shanghai, 200000
Shanghai, Shanghai, 200000

Tracking Information

NCT #
NCT01998620
Collaborators
Not Provided
Investigators
  • Principal Investigator: Liang Chen Public Health Clinical Center Affiliated to Fudan University
  • Liang Chen Public Health Clinical Center Affiliated to Fudan University