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Pioglitazone in Hepatitis C

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ClinicalTrials.gov Identifier: NCT00189163
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hari S. Conjeevaram, University of Michigan

Study Description
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Brief Summary:
The presence of insulin resistance (IR) appears to be a key factor in the development of steatosis and disease progression in patience with Hepatitis C virus (HCV) genotype-1 infections similar to levels in Non-alcoholic fatty liver disease (NAFLD). The objective of this study is to determine whether Pioglatizone, when given along with Interferon and Ribavirin, reduces insulin resistance and lowers HCV viral levels and improved response in patients who have HCV genotype-1 infection when compared to a placebo.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Pioglitazone Drug: Placebo Oral Tablet Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pioglitazone in Hepatitis C: A Randomized, Double Blind, Placebo-controlled Study
Study Start Date : January 2005
Actual Primary Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pioglitazone
30 mg, taken orally, once per day
 Drug: Pioglitazone
30 mg, taken orally, once per day, for 48 weeks
Other Name: Actos
Placebo Comparator: Placebo
Sugar pill, taken orally, once a day
 Drug: Placebo Oral Tablet
Sugar Pill, taken orally, once per day, for 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Virologic Response [ Time Frame: 72 weeks ]
    Measuring HCV RNA in serum (detectable or undetectable)


Secondary Outcome Measures :
  1. Change from Baseline in Insulin Sensitivity [ Time Frame: 72 weeks ]
    HOMA Index

  2. Change from Baseline in Histology [ Time Frame: 60 weeks ]
    ISHAK Score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All eligible adult patients with compensated liver disease due to chronic infection with HCV and genotype 1 infection who are treatment naïve will be enrolled into the study.
  • All racial and ethnic groups will be recruited into this study.
  • Males and females: age > 18 years
  • Chronic hepatitis C: history of serum positive for HCV antibody (anti-HCV) and HCV RNA. Patients should have evidence of chronic hepatitis with a minimum fibrosis score of 1 on liver biopsy done within 6 months of enrollment.
  • Insulin resistance based on HOMA index value (HOMA-IR) of > 2.0 during screening. HOMA-IR is a well recognized and validated index of insulin resistance in both non-diabetic and diabetic populations and has been shown to have a good correlation with 'clamp' techniques that are intensive. HOMA is also used routinely to assess longitudinal changes including assessment of the effects of treatment. In general, a HOMA-IR value of > 1.5 is considered abnormal based on repeat testing measurements performed by both HOMA assessment and by euglycemic clamp technique and is considered representative of decreased insulin sensitivity. Although insulin secretion is pulsatile, the correlation between HOMA computed from repeat sampling (using a mean of three samples taken at 5-minute intervals to compute HOMA) and the value obtained from a single basal sample to determine insulin sensitivity has been shown to be near perfect even in patients with type 2 diabetes (r = 0.99, p < 0.0001). The investigators will use a HOMA-IR value of > 2.0 as part of the inclusion criteria in this study.
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Hepatitis C patients who underwent previous therapy for their liver disease
  • Genotype other than type 1
  • Histological evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC)
  • Patients with cirrhosis and decompensated liver disease and any patient, in whom a liver biopsy is contraindicated, will be excluded.
  • Evidence of other causes of chronic liver disease
  • Diabetes mellitus
  • New York Heart Association (NYHA) functional classification for cardiac disease: class III and IV patients
  • Human immunodeficiency virus (HIV) antibody positive
  • Patients with solid organ transplants
  • Pregnancy or breast feeding
  • Participation in any other clinical trial within 90 days of entry into this trial.
  • Unwilling to consent to the study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189163


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Hari S Conjeevaram, M.D. University of Michigan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hari S. Conjeevaram, Associate Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00189163     History of Changes
Other Study ID Numbers: pio-hcv-108
IRB Protocol Number: 2004-0883
GCRC Protocol Number: 2085
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Keywords provided by Hari S. Conjeevaram, University of Michigan:
Hepatitis C
Genotype 1
Insulin Resistance
Pioglitazone

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs