The Effect of Adding Metformin to the Treatment of Hepatitis C | RxWiki

The Effect of Adding Metformin to the Treatment of Hepatitis C

Overview[ - collapse ][ - ]

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	Hepatitis C
Intervention	Drug: Metformin Drug: pegylated interferon Drug: Ribavirin
Phase	Phase 4
Sponsor	Tehran University of Medical Sciences
Responsible Party	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier	NCT00560690
First Received	November 19, 2007
Last Updated	July 31, 2011
Last verified	July 2011

Tracking Information[ + expand ][ + ]

First Received Date	November 19, 2007
Last Updated Date	July 31, 2011
Start Date	December 2007
Estimated Primary Completion Date	December 2010
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

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
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	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Hepatitis C
Intervention	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
Study Arm (s)	Placebo Comparator: Placebo standard treatment with pegylated interferon and ribavirin + placebo Experimental: Metformin standard treatment with pegylated interferon and ribavirin + metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	130
Estimated Completion Date	December 2010
Estimated Primary Completion Date	September 2010
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
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00560690
Other Study ID Numbers	83/53
Has Data Monitoring Committee	No
Information Provided By	Tehran University of Medical Sciences
Study Sponsor	Tehran University of Medical Sciences
Collaborators	Not Provided
Investigators	Principal Investigator: Shahin Merat, MD Digestive Disease Research Center, Medical Sciences / University of TehranStudy Chair: Reza Malekzadeh, MD Digestive Disease Research Center, Medical Sciences / University of Tehran
Verification Date	July 2011

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