We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Adding Metformin to the Treatment of Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560690
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Metformin Drug: pegylated interferon Drug: Ribavirin Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Primary Completion Date : September 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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: 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


Outcome Measures

Primary Outcome Measures :
  1. Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment [ Time Frame: 6 months after end of treatment ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shahin Merat, Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00560690     History of Changes
Other Study ID Numbers: 83/53
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Shahin Merat, 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
Metformin
Interferons
Ribavirin
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action