Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
NCT ID: NCT01998620
Last Updated: 2014-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2013-11-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ademetionine 1
Ademetionine 2000mg
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
Ademetionine 2
Ademetionine 1000mg
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
Ademetionine 3
no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Interventions
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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
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
Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Eligibility Criteria
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Inclusion Criteria
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
2. liver failure
3. non-hepatic diseases caused jaundice
4. obstructive jaundice
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Hisun Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Liang Chen
Role: PRINCIPAL_INVESTIGATOR
Public Health Clinical Center Affiliated to Fudan University
Locations
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Public Health Clinical Center Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XMX-HBV-001
Identifier Type: -
Identifier Source: org_study_id
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