A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN (NATURAL HISTORY-HCV)

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Signed Informed Consent

• HCV- infected patients confirmed by PCR or branched DNA (b-DNA)

• Scheduled to commence combination RBV/IFN or RBV/PEG-IFN therapy on Day 1

• Normal serum creatinine

• Life expectancy > 6 months

Exclusion Criteria:

• HIV-infected patients

• History of any primary hematologic disease

• Anemia attributable to factors such as iron or folate deficiency, pre-treatment

• hemolysis or gastrointestinal bleeding

• Has suspected or confirmed significant hepatic disease from an etiology other than

• HCV (e.g. alcohol, HBV, autoimmune disease etc)

• Current, active substance abuser

• Pregnant or breast feeding

• Women of childbearing potential not taking adequate birth control measures

• Exposure to Epoetin alfa within three (3) months prior to study enrollment or during study

• Transfusion within three (3) months prior to study entry