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Completed

NCT Number: NCT00211042

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

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Key information

Conditions

Pure Red-Cell Aplasia Anemia Hematologic Diseases Hemic and Lymphatic Diseases Red-Cell Aplasia, Pure

Sex eligibility

All sexes

Study type

Observational

Primary location

Santos, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is an observational study. No medication will be given to the participants. Participants will receive standard-of-care treatment from their individual physicians.

Primary outcomes

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

    Time frame: Up to 24 months after the date of loss of efficacy

    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.

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

    Time frame: Up to 2 years after the enrollment in the extended observation phase

    Participants remaining anti-epoetin alfa positive 24 months after loss of efficacy will enter in the extended observation period.

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

    Time frame: Up to 24 months after the date of loss of efficacy

    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.

  4. Overall clinical outcome of pure red cell aplasia (Extended observation phase)

    Time frame: Up to 2 years after the enrollment in the extended observation phase

Secondary outcomes

  1. Different treatment modalities with pure red cell aplasia outcome (Initial observation phase)

    Time frame: Up to 24 months after the date of loss of efficacy

  2. Different treatment modalities with pure red cell aplasia outcome (Extended observation phase)

    Time frame: Up to 2 years after the enrollment in the extended observation phase

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

    Time frame: Period between LOE date and date of enrollment in the study

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Observational, Multicenter Study of Subjects With Pure Red Cell Aplasia Associated With r-HuEPO Treatment

Important dates

Study start
2004
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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