The Effect of Adding Metformin to the Treatment of Hepatitis C

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Drug: Metformin; Drug: pegylated interferon

Study type: Interventional

Funder types: Other

Identifiers

NCT00560690

83/53

Details and patient eligibility

About

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

Full description

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

Enrollment: 140 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

standard treatment with pegylated interferon and ribavirin + placebo

Treatment:

Drug: pegylated interferon

Drug: Ribavirin

Metformin

Experimental group

Description:

standard treatment with pegylated interferon and ribavirin + metformin

Treatment:

Drug: pegylated interferon

Drug: Ribavirin

Drug: Metformin