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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)

This study has been completed.
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00328549
First received: May 19, 2006
Last updated: May 17, 2011
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C
Anemia
 Drug: Pegylated Interferon and Ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ortho Biotech Products, L.P.:

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

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

Enrollment: 105
Study Start Date: October 2001
Study Completion Date: December 2002
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328549

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

Additional Information:
A Study to Evaluate the Erythropoietic Response in HCV Patients Receiving Combination Ribavirin/Interferon Therapy or Ribavirin/PEG-Interferon  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00328549     History of Changes
Other Study ID Numbers: CR005116
Study First Received: May 19, 2006
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anemia
Hepatitis
Hepatitis A
Hepatitis C
Hematologic Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013