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

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

Criteria

Inclusion Criteria:

1. from 18-65 years old

2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)

3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criteria:

1. liver mass, liver carcinoma

2. liver failure

3. non-hepatic diseases caused jaundice

4. obstructive jaundice