Metformin Therapy in HCV Infection

Chronic Hepatitis C Infection Clinical Trial

Official title:

A Study of the Antiviral Activity of Metformin as an Anti-Hepatitis C Virus Agent in Patients With Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972723
• Other study ID #: 10ID003
• Secondary ID: 2010-022850-18
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2016
• Last updated: November 22, 2016
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection.

A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult Males and Females (18-70 yrs old) able to give consent

• Chronic hepatitis C virus infection

• Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study; (e.g.intra-uterine device (IUD) or a double-barrier method of oral contraception with condom)

Exclusion Criteria:

• Type 2 diabetes.

• Patients with impaired renal function.

• Decompensated liver cirrhosis (stable patients with cirrhosis would be eligible).

• Patients who in the opinion of the Investigator are considered unsuitable.

• Pregnant females.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• Metformin
Oral Metformin 1g bd. (total = 2g per day) for 14 days

Locations

Country	Name	City	State
United Kingdom	Secondary care Hepatitis clinic at Nottingham University Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop of viral load by at least 1 log in patients receiving Metformin		14 days	Yes