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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01998620

Enrollment

240

Registered

2013-12-02

Start date

2013-11-30

Completion date

2015-05-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis, Hepatitis B

Keywords

Hepatitis B, Cholestasis

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

Interventions

DRUGAdemetionine 2

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

DRUGAdemetionine 1

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

DRUGAdemetionine 3

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
levels of serum total bilirubin declined from baseline	2 weeks	levels of serum total bilirubin declined from baseline
Alkaline Phosphatase	10 weeks	Alkaline Phosphatase
Gamma-Glutamyl Transpeptidase	10 weeks	Gamma-Glutamyl Transpeptidase

Secondary

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

Countries

China

Contacts

Primary ContactLiang Chen

chenlian@shaphl.org00862137990333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026