The Effect of Adding Metformin to the Treatment of Hepatitis C

April 2, 2015 updated by: Shahin Merat, Tehran University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic hepatitis C
  • Iranian nationality
  • Treatment naive

Exclusion Criteria:

  • cirrhosis
  • diabetes mellitus
  • HBV/HIV coinfection
  • contraindications of metformin, interferon, ribavirin
  • severe medical conditions (e.g. CHF, CRF, psychosis, ...)
  • not consenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
standard treatment with pegylated interferon and ribavirin + placebo
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
Experimental: Metformin
standard treatment with pegylated interferon and ribavirin + metformin
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
Drug: Metformin
500 mg oral three times a day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Time Frame: 6 months after end of treatment
6 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse effects leading to discontinuation of treatment
Time Frame: anytime during the study
anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment
Time Frame: one month after start of treatment
one month after start of treatment
Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment
Time Frame: three months after start of treatment
three months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Shahin Merat, MD, Digestive Disease Research Center, Medical Sciences / University of Tehran
  • Study Chair: Reza Malekzadeh, MD, Digestive Disease Research Center, Medical Sciences / University of Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83/53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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