Status:
COMPLETED
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)
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Hepatitis C
Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
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 modera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00328549
Start Date
October 1 2001
End Date
December 1 2002
Last Update
May 19 2011
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