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
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis c
Insulin Resistance
Drug: metformin
Drug: pegylated-IFN
Drug: ribavirin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • RVR [ Time Frame: HCV RNA At 4 weeks ] [ Designated as safety issue: Yes ]
    HCV RNA At 4 weeks


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin, pegylated-IFN, ribavirin
metformin,pegylated-IFN and ribavirin
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
Placebo Comparator: Pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
Drug: pegylated-IFN
pegasys 180 mcg qw
Other Name: pegasys
Drug: ribavirin
ribavirin 800-1200 mg qd according to BW

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664845

Contacts
Contact: Wei-Lun Tsai, MD 886-7-3422121 ext 2075 tsaiwl@yahoo.com.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Wei-Lun Tsai, MD    886-7-3422121 ext 2075    tsaiwl@yahoo.com.tw   
Principal Investigator: Wei-Lun Tsai, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Wei-Lun Tsai, MD Department of Gastroenterology, Kaohsoung Veterans General Hospital
  More Information

No publications provided

Responsible Party: Wei-Lun Tsai, Attending physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01664845     History of Changes
Other Study ID Numbers: VGHKS12-CT3-16
Study First Received: August 10, 2012
Last Updated: August 13, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Veterans General Hospital.:
hepatitis c
metformin
pegylated interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Metformin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on April 16, 2014