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The Effect of Adding Metformin to the Treatment of Hepatitis C

NCT00560690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-04-06

No results posted yet for this study

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

Conditions

  • Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Shahin Merat, MD · Digestive Disease Research Center, Medical Sciences / University of Tehran

  • Reza Malekzadeh, MD · Digestive Disease Research Center, Medical Sciences / University of Tehran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560690 on ClinicalTrials.gov