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Pioglitazone in Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hari S. Conjeevaram, University of Michigan
ClinicalTrials.gov Identifier:
NCT00189163
First received: September 13, 2005
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Chronic Hepatitis C
Drug: Pioglitazone
Drug: Placebo Oral Tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pioglitazone in Hepatitis C: A Randomized, Double Blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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


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

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


Enrollment: 40
Study Start Date: January 2005
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received: September 13, 2005
Last Updated: December 15, 2016

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2017