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

Phase 4

• Conditions: Hepatitis B; Cholestasis
• Interventions: Drug: Ademetionine 1; Drug: Ademetionine 2; Drug: Ademetionine 3

• Registration Number: NCT01998620
• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ademetionine 1	Ademetionine 1	Ademetionine 2000mg
Ademetionine 2	Ademetionine 2	Ademetionine 1000mg
Ademetionine 3	Ademetionine 3	no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Primary Outcome Measures

Name	Time	Method
Alkaline Phosphatase	10 weeks	Alkaline Phosphatase
Gamma-Glutamyl Transpeptidase	10 weeks	Gamma-Glutamyl Transpeptidase
levels of serum total bilirubin declined from baseline	2 weeks	levels of serum total bilirubin declined from baseline

Secondary Outcome Measures

Name	Time	Method
glutamic pyruvic transaminase	2 weeks, 6 weeks, 10 weeks	glutamic pyruvic transaminase
level of serum bile acids decline from baseline	2 weeks, 6 weeks, 10 weeks	level of serum bile acids decline from baseline
glutamic oxaloacetic transaminase	2 weeks, 6 weeks, 10 weeks	glutamic oxaloacetic transaminase
level of serum direct bilirubin decline from baseline	2 weeks, 6 weeks, 10 weeks	level of serum direct bilirubin decline from baseline

Trial Locations

Locations (1)

Public Health Clinical Center Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China