Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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.