Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Study Overview
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Brief Summary
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The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).

Detailed Description
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Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.

Official Title
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Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Conditions
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Chronic Hepatitis c, Insulin Resistance

Intervention / Treatment
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* Drug: metformin
* Drug: pegylated-IFN
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA (+) and ALT > 40 U/L Compensated liver HOMA-IR > 2 Exclusion Criteria: neutrophil <1500/mm3 male: Hb < 13 g/dl, female: Hb < 12 g/dl platelet < 80,000 /mm3 Cr > 2.5 mg/dl Alcohol use > 20 gm per day uncontrolled depression, thyroid disease, autoimmune disease Pregnancy Hepatocellular carcinoma allergy to interferon or ribavirin Diabetes HBV/HIV co-infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin, pegylated-IFN, ribavirin<br>metformin,pegylated-IFN and ribavirin | Drug: metformin<br>* metformin 500mg tid<br>* Other names: glucophage;Drug: pegylated-IFN<br>* pegasys 180 mcg qw<br>* Other names: pegasys;Drug: ribavirin<br>* ribavirin 800-1200 mg qd according to BW<br>|
| Placebo Comparator: Pegylated-IFN and ribavirin<br>pegylated -IFN and ribavirin | Drug: pegylated-IFN<br>* pegasys 180 mcg qw<br>* Other names: pegasys;Drug: ribavirin<br>* ribavirin 800-1200 mg qd according to BW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained virological response | HCV RNA negative 24 weeks after treatment is stopped | 24 weeks after treatment is stopped | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of HOMA-IR | Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment | Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis c, metformin, pegylated interferon