A Study of Patients With Pure Red Cell Aplasia Associated With Recombinant Human Erythropoietin Treatment
NCT ID: NCT00211042
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2004-02-29
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Santos, , Brazil
São Paulo, , Brazil
Saskatoon, Saskatchewan, Canada
Darmstadt, , Germany
Hannoversch Münden, , Germany
Tvnsberg, , Norway
Bloemfontein, , South Africa
Karlshamn, , Sweden
Linköping, , Sweden
Stockholm, , Sweden
Trollhättan, , 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
Countries
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Other Identifiers
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EPO-IMU-301
Identifier Type: OTHER
Identifier Source: secondary_id
CR004393
Identifier Type: -
Identifier Source: org_study_id
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