Pure Red-cell Aplasia Clinical Trial
Official title:
Observational, Multicenter Study of Subjects With Pure Red Cell Aplasia Associated With r-HuEPO Treatment
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 previously treated with recombinant human erythropoietin.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Brazil, Canada, Germany, Norway, South Africa, Sweden, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with Pure Red Cell Aplasia (PRCA) outcome (Initial observation phase) | 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. | Up to 24 months after the date of loss of efficacy | No |
Primary | Number of participants with pure red cell aplasia outcome (Extended observation phase) | Participants remaining anti-epoetin alfa positive 24 months after loss of efficacy will enter in the extended observation period. | Up to 2 years after the enrollment in the extended observation phase | No |
Primary | Overall clinical outcome of pure red cell aplasia (Initial observation phase) | 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. | Up to 24 months after the date of loss of efficacy | No |
Primary | Overall clinical outcome of pure red cell aplasia (Extended observation phase) | Up to 2 years after the enrollment in the extended observation phase | No | |
Secondary | Different treatment modalities with pure red cell aplasia outcome (Initial observation phase) | Up to 24 months after the date of loss of efficacy | No | |
Secondary | Different treatment modalities with pure red cell aplasia outcome (Extended observation phase) | Up to 2 years after the enrollment in the extended observation phase | No | |
Secondary | Risk factors for Loss of Efficacy (LOE) and pure red cell aplasia (PRCA) outcome | 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. | Period between LOE date and date of enrollment in the study | No |
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