Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Peginterferon, Ribavirin, Procrit, Epoetin-alpha
Eligibility Criteria
Inclusion Criteria: HCV RNA positive in serum HCV genotype 1 Liver histology consistent with chronic HCV performed within 24 months prior to starting medication in this study Exclusion Criteria: Previous interferon treatment Any other cause for liver disease Hemoglobin >10 gm/dl WBC >3,000/cubic mm Platelet count > 80,000/cubic mm Serum albumin < 3.5 gm.dl Conjugated serum bilirubin > 2.0 mg/dl INR > 1.5 Positive HIV test Refusal to use adequate contraception in female subjects or the spouse.sexual partners of male subjects An elevation in TSH (thyroid stimulating hormone). Patients with a pre-existing thyroid disorder may enter the study if their TSH level can be maintained within the normal range. Women who are pregnant or breast feeding. A history of decompensated liver disease defined as presence of ascites, bleeding esophageal or gastric varices or hepatic encephalopathy. Patients with active alcohol/drug use. Patients with active psychiatric disorders which might be exacerbated by interferon therapy including schizophrenia and severe depression. Use of any immune suppressive medications within 3 months of starting interferon therapy. A history of cardiac disease to include recent myocardial infarction or angina. Patients with previous exposure to Procrit, Aranesp, GA_EPO, or any other Epoetin formulations, within 6 months prior to enrollment in this study. Patients with known sensitivity to mammalian cell-derived products. Patients with known hypersensitivity to human albumin. Patients unable to provide informed consent. Any other medical condition which the primary investigator feels might be exacerbated or jeopardise the patient's participation in this study.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
1
2
3
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.