The Effect of Adding Metformin to the Treatment of Hepatitis C

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Metformin; Drug: pegylated interferon; Drug: Ribavirin

• Registration Number: NCT00560690
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Study Start: 2007-12
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	pegylated interferon	standard treatment with pegylated interferon and ribavirin + metformin
Metformin	Metformin	standard treatment with pegylated interferon and ribavirin + metformin
Placebo	pegylated interferon	standard treatment with pegylated interferon and ribavirin + placebo
Placebo	Ribavirin	standard treatment with pegylated interferon and ribavirin + placebo
Metformin	Ribavirin	standard treatment with pegylated interferon and ribavirin + metformin

Primary Outcome Measures

Name	Time	Method
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment	6 months after end of treatment

Secondary Outcome Measures

Name	Time	Method
adverse effects leading to discontinuation of treatment	anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment	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	three months after start of treatment

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of