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

Last updated: August 13, 2012
Sponsor: Kaohsiung Veterans General Hospital.
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Hepatitis

Diabetes Prevention

Stress

Treatment

N/A

Clinical Study ID

NCT01664845
VGHKS12-CT3-16
  • Ages 20-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HCV RNA (+) and ALT > 40 U/L

  • Compensated liver

  • HOMA-IR > 2

Exclusion

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

Study Design

Total Participants: 120
Study Start date:
August 01, 2012
Estimated Completion Date:
August 31, 2014

Study Description

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.

Connect with a study center

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 813
    Taiwan

    Active - Recruiting

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