Chronic Hepatitis C
Conditions
Keywords
HCV
Brief 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.
Detailed description
The relationship between HCV and IR is an evolving one. This study will allow a more formal evaluation of this relationship. Four hundred patients will be treated using weight based Peg Intron and Rebetol. Clinical and biochemical data related to IR will be collected to determine if any such factors can predict who will have a sustained virological response. To evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.
Interventions
DRUGPEG-Intron Plus REBETOL
Sponsors
Schering-Plough
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in treatment response rates between those with insulin resistance those without. | — |
Secondary
| Measure | Time frame |
|---|---|
| Which marker of Insulin Resistance (i.e. the HOMA score, Waste Circumference or BMI) is the best measure for risk of hypo responsiveness. | — |
Outcome results
None listed