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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01664845
Recruitment Status : Unknown
Verified August 2012 by Wei-Lun Tsai, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.

Tracking Information
First Submitted Date  ICMJE August 10, 2012
First Posted Date  ICMJE August 14, 2012
Last Update Posted Date August 14, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
sustained virological response [ Time Frame: 24 weeks after treatment is stopped ]
HCV RNA negative 24 weeks after treatment is stopped
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
change of HOMA-IR [ Time Frame: Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment ]
Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2012)
RVR [ Time Frame: HCV RNA At 4 weeks ]
HCV RNA At 4 weeks
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Official Title  ICMJE Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Brief 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).
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis c
  • Insulin Resistance
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 13, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01664845
Other Study ID Numbers  ICMJE VGHKS12-CT3-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei-Lun Tsai, MD Department of Gastroenterology, Kaohsoung Veterans General Hospital
PRS Account Kaohsiung Veterans General Hospital.
Verification Date August 2012

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