Pioglitazone in Hepatitis C - Full Text View

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Hari S. Conjeevaram, 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

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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 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

ClinicalTrials.gov processed this record on June 28, 2017