The Effect of Adding Metformin to the Treatment of Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
pegylated interferon
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, metformin, Insulin Resistance
Eligibility 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
Sites / Locations
- Shariati Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Metformin
Arm Description
standard treatment with pegylated interferon and ribavirin + placebo
standard treatment with pegylated interferon and ribavirin + metformin
Outcomes
Primary Outcome Measures
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Secondary Outcome Measures
adverse effects leading to discontinuation of treatment
Rapid viral response, defined as undetectable viral RNA 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
Full Information
NCT ID
NCT00560690
First Posted
November 19, 2007
Last Updated
April 2, 2015
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00560690
Brief Title
The Effect of Adding Metformin to the Treatment of Hepatitis C
Official Title
Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. 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
Detailed Description
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, metformin, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
standard treatment with pegylated interferon and ribavirin + placebo
Arm Title
Metformin
Arm Type
Experimental
Arm Description
standard treatment with pegylated interferon and ribavirin + metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500 mg oral three times a day for 6 months
Intervention Type
Drug
Intervention Name(s)
pegylated interferon
Intervention Description
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Primary Outcome Measure Information:
Title
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Time Frame
6 months after end of treatment
Secondary Outcome Measure Information:
Title
adverse effects leading to discontinuation of treatment
Time Frame
anytime during the study
Title
Rapid viral response, defined as undetectable viral RNA one month after start of treatment
Time Frame
one month after start of treatment
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahin Merat, MD
Organizational Affiliation
Digestive Disease Research Center, Medical Sciences / University of Tehran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reza Malekzadeh, MD
Organizational Affiliation
Digestive Disease Research Center, Medical Sciences / University of Tehran
Official's Role
Study Chair
Facility Information:
Facility Name
Shariati Hospital
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Adding Metformin to the Treatment of Hepatitis C
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