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

NCT00926016 | Completed DMC

• 1 other identifier: C.2006.152
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Improvement in baseline viremia and viral kinetics, and/or pro-inflammatory cytokines decrease, and/or markers of innate immunity are upregulated to position a more favorable response to current CHC therapy.

  104 days

Study Arms (2)

pioglitazone

ACTIVE COMPARATOR

Treatment with pioglitazone 45 mg a day for 3 months

Drug: Pioglitazone (Actos)

No intervention

NO INTERVENTION

Monitoring period without pioglitazone for 3 months

Interventions

Pioglitazone (Actos) DRUG

pioglitazone 45 mg a day

pioglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen A Harrison, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)