Pioglitazone in Hepatitis C
3 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedDecember 16, 2016
December 1, 2016
2.9 years
September 13, 2005
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virologic Response
Measuring HCV RNA in serum (detectable or undetectable)
72 weeks
Secondary Outcomes (2)
Change from Baseline in Insulin Sensitivity
72 weeks
Change from Baseline in Histology
60 weeks
Study Arms (2)
Pioglitazone
ACTIVE COMPARATOR30 mg, taken orally, once per day
Placebo
PLACEBO COMPARATORSugar pill, taken orally, once a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Able and willing to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hari S Conjeevaram, M.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2007
Last Updated
December 16, 2016
Record last verified: 2016-12