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The Effect of Adding Metformin to the Treatment of Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00560690
First received: November 19, 2007
Last updated: July 31, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatitis C
 Drug: Metformin
Drug: pegylated interferon
Drug: Ribavirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment [ Time Frame: 6 months after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse effects leading to discontinuation of treatment [ Time Frame: anytime during the study ] [ Designated as safety issue: Yes ]
  • Rapid viral response, defined as undetectable viral RNA one month after start of treatment [ Time Frame: one month after start of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560690

Locations
Iran, Islamic Republic of
Shariati Hospital
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Reza Malekzadeh, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00560690     History of Changes
Other Study ID Numbers: 83/53
Study First Received: November 19, 2007
Last Updated: July 31, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Hepatitis C
metformin
Insulin Resistance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
 Ribavirin
Metformin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013