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

This study is currently recruiting participants.
Verified August 2012 by Kaohsiung Veterans General Hospital.
Sponsor:
Information provided by (Responsible Party):
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01664845
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes

August 10, 2012
August 13, 2012
August 2012
August 2014   (final data collection date for primary outcome measure)
sustained virological response [ Time Frame: 24 weeks after treatment is stopped ] [ Designated as safety issue: No ]
HCV RNA negative 24 weeks after treatment is stopped
Same as current
Complete list of historical versions of study NCT01664845 on ClinicalTrials.gov Archive Site
change of HOMA-IR [ Time Frame: Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment ] [ Designated as safety issue: No ]
Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Same as current
RVR [ Time Frame: HCV RNA At 4 weeks ] [ Designated as safety issue: Yes ]
HCV RNA At 4 weeks
Same as current
 
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

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).

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis c
  • Insulin Resistance
  • Drug: metformin
    metformin 500mg tid
    Other Name: glucophage
  • Drug: pegylated-IFN
    pegasys 180 mcg qw
    Other Name: pegasys
  • Drug: ribavirin
    ribavirin 800-1200 mg qd according to BW
  • Active Comparator: metformin, pegylated-IFN, ribavirin
    metformin,pegylated-IFN and ribavirin
    Interventions:
    • Drug: metformin
    • Drug: pegylated-IFN
    • Drug: ribavirin
  • Placebo Comparator: Pegylated-IFN and ribavirin
    pegylated -IFN and ribavirin
    Interventions:
    • Drug: pegylated-IFN
    • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Wei-Lun Tsai, MD 886-7-3422121 ext 2075 tsaiwl@yahoo.com.tw
Taiwan
 
NCT01664845
VGHKS12-CT3-16
No
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
Not Provided
Principal Investigator: Wei-Lun Tsai, MD Department of Gastroenterology, Kaohsoung Veterans General Hospital
Kaohsiung Veterans General Hospital.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP