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)

Centocor Ortho Biotech

Status and phase

Completed

Phase 2

Conditions

Anemia

Hepatitis C

Treatments

Drug: Pegylated Interferon and Ribavirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328549

CR005116

Details and patient eligibility

About

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.

Full description

Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin (Hb) decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in Hb can result in RBV dose reduction or discontinuation, which may adversely affect the likelihood of a virologic response. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells. Normally, a decrease in the Hb level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hb level. The relationship between Hb and sEPO is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia.

One hundred HCV-infected patients who are receiving combination RBV/IFN or RBV/PEG-IFN therapy will be enrolled in this multicenter study. No study medication will be administered during this study. Weekly blood samples will be collected at specified times during the initial 8 weeks of RBV/IFN or RBV/PEG-IFN therapy. Assessment of laboratory tests, vital signs, incidence and severity of adverse experiences will be obtained.

The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment, up to Week 8) in HCV-infected patients receiving combination therapy with RBV/IFN or RBV/PEG-IFN. N/A

Enrollment

105 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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