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Completed

NCT Number: NCT00560690

The Effect of Adding Metformin to the Treatment of Hepatitis C

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Glucose Metabolism Disorders Hepatitis Hepatitis, Viral, Human Hyperinsulinism Infections Insulin Resistance Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Virus Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shariati Hospital

Tehran, Tehran Province, 14114, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

500 mg oral three times a day for 6 months

Pegylated interferon

Drug

180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype

Ribavirin

Drug

800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

Primary outcomes

  1. Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment

    Time frame: 6 months after end of treatment

Secondary outcomes

  1. adverse effects leading to discontinuation of treatment

    Time frame: anytime during the study

  2. Rapid viral response, defined as undetectable viral RNA one month after start of treatment

    Time frame: one month after start of treatment

  3. 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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2007
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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