Pioglitazone on Viral Kinetics, Cytokines and Innate Immunity in Insulin Resistant CHC GT 1 Subjects

Completed · Not applicable

Conditions studied: Chronic Hepatitis C

In brief

The purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.

Key facts

Study ID

NCT00926016

Run by

Brooke Army Medical Center

People needed

23

Starts

2006-06-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV-Ab or HCV-RNA by PCR Positive for at least six months (to rule out acute seroconversion)
• Serum positive for HCV-RNA by PCR assay
• Must have insulin resistance, defined as a QUICKI score < 0.35. QUICKI
• Liver biopsy consistent with CHC within 24 months prior to enrollment
• Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
• Hemoglobin values of >12 gm/dL for females and >13 gm/dL for males.
• WBC >3,000/ mm3
• Neutrophil count > 1,500/mm3
• Platelets >65,000/ mm3
• Direct bilirubin, within 20% of ULN
• Indirect bilirubin, within normal limits (WNL)
• Albumin >3gm/dL
• Serum creatinine < 20% above the ULN
• TSH WNL
• Alpha fetoprotein value < 100 ng/mL

You may not qualify if…

• Prior interferon based therapy
• Use of insulin
• Fasting glucose levels > 200 mg/dl
• Women who are pregnant or breast-feeding
• No other thiazolidinedione after liver biopsy and/or during the entire study (
• Hepatitis C of non-genotype 1
• Suspected hypersensitivity to pioglitazone
• Any cause for liver disease other than chronic hepatitis C, insulin resistance, or NAFLD, including but not limited to:
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Co-infection with HBV
• Wilson's disease
• Autoimmune hepatitis
• Significant alcohol use
• Drug-related liver disease
• Any condition that would prevent the subject from having a liver biopsy.
• Hemoglobinopathies that could potentially compromise patient safety
• Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
• Participants with organ transplants other than cornea and hair transplant.
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
• Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
• Substance abuse, such as alcohol, IV drugs and inhaled drugs
• Alcohol consumption is to be strongly discouraged
• Seizure disorders not controlled with medication
• Significant cardiovascular dysfunction within the past 12 months

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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