UnknownPhase 4

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

China240 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

levels of serum total bilirubin declined from baseline

Timeframe: 2 weeks

Alkaline Phosphatase

Timeframe: 10 weeks

Gamma-Glutamyl Transpeptidase

Timeframe: 10 weeks

Trial details

NCT IDNCT01998620

SponsorZhejiang Hisun Pharmaceutical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

Contact for this trial

Liang Chen

00862137990333 chenlian@shaphl.org

View on ClinicalTrials.gov More Hepatitis B trials