NCT00560690

The Effect of Adding Metformin to the Treatment of Hepatitis C

Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients 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

Detailed description

Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Metformin	500 mg oral three times a day for 6 months
DRUG	pegylated interferon	180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
DRUG	Ribavirin	800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2007-11-20
• Last updated: 2015-04-06

Locations

1 site across 1 country: Iran