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A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

29. august 2013 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. The study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study. In the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. During this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. Safety evaluations will include assessment of adverse events which will be monitored throughout the study. The total duration of the study will be 3 years.

Studietype

Observasjonsmessig

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants with positive or borderline serum anti erythropoietin antibody titer and who are responding to any erythropoietin receptor agonist (ERA) therapy for any cause of anemia

Beskrivelse

Inclusion Criteria:

  • Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
  • Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
  • Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
  • An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
  • If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L

Exclusion Criteria:

  • Stem cell or bone marrow transplantation
  • Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
  • Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia [a rise in hemoglobin which lasted for a minimum of 3 months] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Erythropoietin receptor agonist
Participants with borderline serum anti erythropoietin (EPO) antibody (Ab) titers and who are treated with any erythropoietin receptor agonist (ERA) for any indication, having anti-EPO Ab identified by radioimmunoprecipitation (RIP), who are responding to ERA therapy, will be included in the study.
Legemiddel: No intervention
This is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab)
Tidsramme: Up to 2 years
An antibody is a large Y-shaped protein secreted into the blood and is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Presence of anti-EPO Ab will help to find out participant's progress to the outcomes loss of effectiveness, suspected pure red cell aplasia, or confirmed pure red cell aplasia.
Up to 2 years
Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy
Tidsramme: Up to 2 years
Up to 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Concentration of Plasma Anti Erythropoietin Antibody
Tidsramme: Up to 2 years
Up to 2 years
Factors That Forecast Progression to Loss of Effectiveness
Tidsramme: Up to 2 years
Up to 2 years
Factors That Forecast Progression to Suspected Pure Red Cell Aplasia
Tidsramme: Up to 2 years
Up to 2 years
Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia
Tidsramme: Up to 2 years
Up to 2 years
Number of Participants With Adverse Events
Tidsramme: Up to 3 years
Up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2005

Primær fullføring (Forventet)

1. januar 2010

Studiet fullført (Forventet)

1. januar 2010

Datoer for studieregistrering

Først innsendt

13. september 2005

Først innsendt som oppfylte QC-kriteriene

13. september 2005

Først lagt ut (Anslag)

21. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR003277
  • EPO-IMU-302 (Annen identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

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Kliniske studier på Anemi

Kliniske studier på No intervention

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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