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)
1 other identifier
interventional
105
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2001
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 19, 2006
CompletedFirst Posted
Study publicly available on registry
May 22, 2006
CompletedMay 19, 2011
April 1, 2010
May 19, 2006
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoints were change in Hb and sEPO from baseline to week 8 (or early withdrawal)
Secondary Outcomes (1)
Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Balan V, Schwartz D, Wu GY, Muir AJ, Ghalib R, Jackson J, Keeffe EB, Rossaro L, Burnett A, Goon BL, Bowers PJ, Leitz GJ; HCV Natural History Study Group. Erythropoietic response to anemia in chronic hepatitis C patients receiving combination pegylated interferon/ribavirin. Am J Gastroenterol. 2005 Feb;100(2):299-307. doi: 10.1111/j.1572-0241.2005.40757.x.
PMID: 15667486RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 19, 2006
First Posted
May 22, 2006
Study Start
October 1, 2001
Study Completion
December 1, 2002
Last Updated
May 19, 2011
Record last verified: 2010-04