Status:
COMPLETED
A Study of Patients With Pure Red Cell Aplasia Associated With Recombinant Human Erythropoietin Treatment
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Pure Red-cell Aplasia
Eligibility:
All Genders
Brief Summary
The purpose of this study is to investigate the relationship of anti-erythropoietin antibodies to the clinical course and outcome of pure red cell aplasia (PRCA) in participants currently or previousl...
Detailed Description
This is a multicenter (study conducted at multiple sites), observational (study in which the investigators/physicians observe the participant's data and measure their outcomes) study. Approximately 15...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pure red cell aplasia (PRCA) associated with recombinant human erythropoietin (r-HuEPO) treatment
- Anemia unresponsive to r-HuEPO treatment
- PRCA associated with erythropoietin treatment followed by a sudden decrease (more than or equal to 2 gram per deciliter within 30 days) in a previously stable hemoglobin level
- Exclusion criteria:
- \- Participants who are not fulfilling the inclusion criteria
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00211042
Start Date
February 1 2004
End Date
December 1 2006
Last Update
April 30 2013
Active Locations (21)
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1
Santos, Brazil
2
São Paulo, Brazil
3
Saskatoon, Saskatchewan, Canada
4
Darmstadt, Germany