Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
NCT ID: NCT01664845
Last Updated: 2012-08-14
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
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2012-08-31
2014-08-31
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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metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
metformin
metformin 500mg tid
pegylated-IFN
pegasys 180 mcg qw
ribavirin
ribavirin 800-1200 mg qd according to BW
Pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
pegylated-IFN
pegasys 180 mcg qw
ribavirin
ribavirin 800-1200 mg qd according to BW
Interventions
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metformin
metformin 500mg tid
pegylated-IFN
pegasys 180 mcg qw
ribavirin
ribavirin 800-1200 mg qd according to BW
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Compensated liver
* HOMA-IR \> 2
Exclusion Criteria
* male: Hb \< 13 g/dl, female: Hb \< 12 g/dl
* platelet \< 80,000 /mm3
* Cr \> 2.5 mg/dl
* Alcohol use \> 20 gm per day
* uncontrolled depression, thyroid disease, autoimmune disease
* Pregnancy
* Hepatocellular carcinoma
* allergy to interferon or ribavirin
* Diabetes
* HBV/HIV co-infection
20 Years
80 Years
ALL
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Wei-Lun Tsai
Attending physician
Principal Investigators
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Wei-Lun Tsai, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Kaohsoung Veterans General Hospital
Locations
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Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VGHKS12-CT3-16
Identifier Type: -
Identifier Source: org_study_id
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