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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Pure Red-cell Aplasia

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00211042

CR004393

EPO-IMU-301 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 150 participants will be enrolled in this study. The study consists of an initial observation phase and extended observation period. An initial observation phase starting at enrollment and ending when 24 months have elapsed since the date of loss of efficacy (LOE), supplemented with retrospective data collection for the period between LOE date and date of enrollment in the study. Participants remaining epoetin alfa (EPO-Ab) positive 24 months after LOE will enter a 2-year extended observation period. Study visits will take place every month during the initial observation phase and data will be collected every 6 months during the extended observation phase. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored throughout the study. The total study duration for each participant will be approximately for 4 years.

Enrollment: 52 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Pure Red Cell Aplasia (PRCA)

Description:

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).

Treatment:

Other: No intervention