A Phase 4 interventional study of Metformin and pegylated interferon in Hepatitis C, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by Tehran University of Medical Sciences · Phase 4, Interventional, and Treatment
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
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 140 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
standard treatment with pegylated interferon and ribavirin + placebo
Drug: pegylated interferon · Drug: Ribavirin
standard treatment with pegylated interferon and ribavirin + metformin
Drug: Metformin · Drug: pegylated interferon · Drug: Ribavirin
500 mg oral three times a day for 6 months
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment
Time frame: 6 months after end of treatment
adverse effects leading to discontinuation of treatment
Time frame: anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment
Time frame: 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
Time frame: three months after start of treatment
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences