Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
NCT01998620 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2014-05-29
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.
Conditions
- Hepatitis B
- Cholestasis
Interventions
- DRUG
-
Ademetionine 2
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
- DRUG
-
Ademetionine 1
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
- DRUG
-
Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Sponsors & Collaborators
-
Zhejiang Hisun Pharmaceutical Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Liang Chen · Public Health Clinical Center Affiliated to Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
Countries
- China
Study Locations
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