Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborator: Schering-Plough
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative

• HCV Genotype 1

• Liver biopsy within 36 months of enrollment consistent with chronic hepatitis

• Compensated liver disease with laboratory parameters at entry visit as follows:

• Hemoglobin values of > 12 gm/dL

• WBC > 2,500/mm3

• Neutrophil count > 1,000/mm3

• Platelets > 100,000/mm3

• Prothrombin time < 2 seconds prolonged compared to control, or equivalent INR ratio

• Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome.

• Albumin > 3.0 g/dL

• Serum creatinine < 1.4 mg/dL

• Normal thyroid stimulating hormone (TSH) or thyroid disease clinically controlled

• Antinuclear antibodies (ANA)< 1:160

• FBS < 126 mg/dl

• No significant co-existing psychiatric disease

• Free from substance abuse for past 2 years

Exclusion Criteria:

• Previous treatment for HCV.

• Evidence of being HIV positive.

• Hypersensitivity to alpha interferon, Peg Intron or Rebetol.

• Any other causes for chronic liver disease other than chronic hepatitis C besides obesity.

• Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.

• Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy.

• Preexisting medical condition that could interfere with the patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.

• Patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months.

• Patients with a history of organ transplantation will be excluded.

• Patients taking insulin sensitizing drugs.