A Study of Patients With Pure Red Cell Aplasia Associated With Recombinant Human Erythropoietin Treatment

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Pure Red Cell Aplasia (PRCA)Experimental Treatment1 Intervention

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).