A Study of Patients With Pure Red Cell Aplasia Associated With Recombinant Human Erythropoietin Treatment
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|ClinicalTrials.gov Identifier: NCT00211042|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pure Red-cell Aplasia||Other: No intervention||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||Observational, Multicenter Study of Subjects With Pure Red Cell Aplasia Associated With r-HuEPO Treatment|
|Study Start Date :||February 2004|
|Study Completion Date :||December 2006|
Pure Red Cell Aplasia (PRCA)
This study will examine the relationship of the presence of anti-erythropoietin antibodies to the clinical course and outcome of participants currently or previously treated with recombinant human erythropoietin and who have PRCA identified from all notified reports (spontaneous postmarketing reports or from clinical trials reports).
Other: No intervention
This is an observational study. No medication will be given to the participants. Participants will receive standard-of-care treatment from their individual physicians.
- Number of participants with Pure Red Cell Aplasia (PRCA) outcome (Initial observation phase) [ Time Frame: Up to 24 months after the date of loss of efficacy ]The PRCA outcome is measured by anti-epoetin alfa qualitative test. Persistence of PRCA is defined as: 1) absolute reticulocyte count less than 30,000 per cubic millimeter; and/or 2) no reversal of erythroblastopenia on repeated bone marrow testing. Resolution of PRCA is defined as: 1) absolute reticulocyte count greater than or equal to 30,000 per cubic millimeter; and/or 2) reversal of erythroblastopenia on repeated bone marrow testing.
- Number of participants with pure red cell aplasia outcome (Extended observation phase) [ Time Frame: Up to 2 years after the enrollment in the extended observation phase ]Participants remaining anti-epoetin alfa positive 24 months after loss of efficacy will enter in the extended observation period.
- Overall clinical outcome of pure red cell aplasia (Initial observation phase) [ Time Frame: Up to 24 months after the date of loss of efficacy ]The overall clinical outcome is evaluated by anti-epoetin alfa qualitative test. Overall clinical status will be recorded at each visit in the initial and extended observation phases using a categorical scale (improved, same, worsened, death). In case of death, the date and cause of death along with the the date and cause of death will be recorded.
- Overall clinical outcome of pure red cell aplasia (Extended observation phase) [ Time Frame: Up to 2 years after the enrollment in the extended observation phase ]
- Different treatment modalities with pure red cell aplasia outcome (Initial observation phase) [ Time Frame: Up to 24 months after the date of loss of efficacy ]
- Different treatment modalities with pure red cell aplasia outcome (Extended observation phase) [ Time Frame: Up to 2 years after the enrollment in the extended observation phase ]
- Risk factors for Loss of Efficacy (LOE) and pure red cell aplasia (PRCA) outcome [ Time Frame: Period between LOE date and date of enrollment in the study ]This data will be collected retrospectively and the date of LOE will be determined by the sponsor based upon reported data. PRCA duration groups will be summarized by potential risk factors to evaluate the relationship of risk factors to the duration of PRCA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211042
|Sao Paulo, Brazil|
|Saskatoon, Saskatchewan, Canada|
|Hann. Münden, Germany|
|Bloemfontein, South Africa|
|Stockholm N/A, Sweden|
|N/a N/a, Thailand|
|Birmingham, United Kingdom|
|Chelmsford, United Kingdom|
|Edinburgh, United Kingdom|
|London, United Kingdom|
|Manchester, United Kingdom|
|Santander N/A, United Kingdom|
|Telford, United Kingdom|
|Valencia, United Kingdom|
|Westcliff-On-Sea, United Kingdom|
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|