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)

May 17, 2011 updated by: Ortho Biotech Products, L.P.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

105

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho Biotech Products, L.P.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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