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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328549
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : May 19, 2011
Information provided by:
Ortho Biotech Products, L.P.

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Anemia Drug: Pegylated Interferon and Ribavirin Phase 2

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN
Study Start Date : October 2001
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary endpoints were change in Hb and sEPO from baseline to week 8 (or early withdrawal)

Secondary Outcome Measures :
  1. Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328549

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.

Additional Information:
Publications of Results: Identifier: NCT00328549     History of Changes
Other Study ID Numbers: CR005116
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: April 2010

Keywords provided by Ortho Biotech Products, L.P.:
Natural History,
Hepatitis C Infection
Pegylated Interferon

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action