The Effect of Adding Metformin to the Treatment of Hepatitis C

Hepatitis C Clinical Trial

Official title:

Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560690
• Other study ID #: 83/53
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2007
• Last updated: April 2, 2015
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Metformin
500 mg oral three times a day for 6 months
• pegylated interferon
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
• Ribavirin
800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment		6 months after end of treatment	No
Secondary	adverse effects leading to discontinuation of treatment		anytime during the study	Yes
Secondary	Rapid viral response, defined as undetectable viral RNA one month after start of treatment		one month after start of treatment	No
Secondary	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	No