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

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 |

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 |
- Virologic Response [ Time Frame: 72 weeks ]Measuring HCV RNA in serum (detectable or undetectable)
- Change from Baseline in Insulin Sensitivity [ Time Frame: 72 weeks ]HOMA Index
- Change from Baseline in Histology [ Time Frame: 60 weeks ]ISHAK Score

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Hari S Conjeevaram, M.D. | University of Michigan |
Responsible Party: | Hari S. Conjeevaram, Associate Professor of Medicine, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00189163 |
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 |
Hepatitis C Genotype 1 Insulin Resistance Pioglitazone |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |