The Effect of Adding Metformin to the Treatment of Hepatitis C
NCT ID: NCT00560690
Last Updated: 2015-04-06
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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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2007-12-31
2010-12-31
Brief Summary
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We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
standard treatment with pegylated interferon and ribavirin + placebo
pegylated interferon
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
Ribavirin
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Metformin
standard treatment with pegylated interferon and ribavirin + metformin
Metformin
500 mg oral three times a day for 6 months
pegylated interferon
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
Ribavirin
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Interventions
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Metformin
500 mg oral three times a day for 6 months
pegylated interferon
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
Ribavirin
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Eligibility Criteria
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Inclusion Criteria
* Iranian nationality
* Treatment naive
Exclusion Criteria
* diabetes mellitus
* HBV/HIV coinfection
* contraindications of metformin, interferon, ribavirin
* severe medical conditions (e.g. CHF, CRF, psychosis, ...)
* not consenting
15 Years
65 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Shahin Merat
Professor
Principal Investigators
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Shahin Merat, MD
Role: PRINCIPAL_INVESTIGATOR
Digestive Disease Research Center, Medical Sciences / University of Tehran
Reza Malekzadeh, MD
Role: STUDY_CHAIR
Digestive Disease Research Center, Medical Sciences / University of Tehran
Locations
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Shariati Hospital
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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83/53
Identifier Type: -
Identifier Source: org_study_id
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