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Pure Red Cell Aplasia (PRCA) for Pure Red Cell Aplasia

N/A

Waitlist Available

Research Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months after the date of loss of efficacy

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Pure Red Cell Aplasia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months after the date of loss of efficacy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months after the date of loss of efficacy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months after the date of loss of efficacy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Pure Red Cell Aplasia (PRCA) outcome (Initial observation phase)

Number of participants with pure red cell aplasia outcome (Extended observation phase)

Overall clinical outcome of pure red cell aplasia (Initial observation phase)

Secondary study objectives

Risk factors for Loss of Efficacy (LOE) and pure red cell aplasia (PRCA) outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

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Who is running the clinical trial?

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

514 Previous Clinical Trials

844,607 Total Patients Enrolled

Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trialStudy DirectorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

1 Previous Clinical Trials

124 Total Patients Enrolled