Metformin Therapy in HCV Infection
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|ClinicalTrials.gov Identifier: NCT02972723|
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
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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 The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a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?"
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Infection||Drug: Metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Metformin therapy, single arm
Open label trial, participants will be expected to take Metformin twice a day for 2 weeks
Oral Metformin 1g bd. (total = 2g per day) for 14 days
Other Name: Glucophage
- Drop of viral load by at least 1 log in patients receiving Metformin [ Time Frame: 14 days ]
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972723
|Secondary care Hepatitis clinic at Nottingham University Hospital|
|Nottingham, United Kingdom, NG7 2UH|
|Principal Investigator:||Stephen Dr Ryder||Nottingham University Hospitals NHS Trust|
|Responsible Party:||Nottingham University Hospitals NHS Trust|
|Other Study ID Numbers:||
2010-022850-18 ( EudraCT Number )
|First Posted:||November 23, 2016 Key Record Dates|
|Last Update Posted:||November 23, 2016|
|Last Verified:||November 2016|
Metformin Therapy in HCV
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Physiological Effects of Drugs