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

August 13, 2012 updated by: Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Lun Tsai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
Drug: metformin
metformin 500mg tid
Other Names:
  • glucophage
Drug: pegylated-IFN
pegasys 180 mcg qw
Other Names:
  • pegasys
Drug: ribavirin
ribavirin 800-1200 mg qd according to BW
Placebo Comparator: Pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
Drug: pegylated-IFN
pegasys 180 mcg qw
Other Names:
  • pegasys
Drug: ribavirin
ribavirin 800-1200 mg qd according to BW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sustained virological response
Time Frame: 24 weeks after treatment is stopped
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
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
Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
RVR
Time Frame: HCV RNA At 4 weeks
HCV RNA At 4 weeks
HCV RNA At 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Wei-Lun Tsai, MD, Department of Gastroenterology, Kaohsoung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS12-CT3-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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