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Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

28 de setembro de 2018 atualizado por: Pfizer

Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria

The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Tipo de estudo

Observacional

Inscrição (Real)

80

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10249
        • Vivantes Klinikum im Friedrichshain
      • Berlin, Alemanha, 13353
        • Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
      • Blaubeuren, Alemanha, 89143
        • Kinder- und Jugendarzt-Praxis Blaubeuren
      • Bonn, Alemanha, 53127
        • Institute of Experimental Haematology and Transfusion Medicine
      • Brannenburg, Alemanha, 83098
        • Praxis fur Kinder- und Jugendmedizin, Homoopathie
      • Bremen, Alemanha, 28177
        • Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
      • Delmenhorst, Alemanha, 27753
        • Klinikum Delmehorst gGmbH, Padiatrie
      • Duesseldorf, Alemanha, 40225
        • Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
      • Duisburg, Alemanha, 47051
        • CRC Coagulation Research Centre GmbH
      • Halle, Alemanha, 06120
        • Klinikum der Martin-Luther-Universitaet Halle-Wittenberg
      • Hamburg, Alemanha, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Hamburg, Alemanha, 20251
        • Universitaetsklinikum Eppendorf
      • Heidelberg, Alemanha, 69123
        • SRH Kurpfalzkrankenhaus Heidelberg
      • Koeln, Alemanha, 50677
        • Gemeinschaftspraxis fuer Haematologie und Onkologie
      • Memmingen, Alemanha, 87700
        • Klinikum Memmingen, Kinderklinik
      • Muenchen, Alemanha, 80337
        • Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen
      • Tuebingen, Alemanha, 72076
        • Universitaetsklinik fuer Kinder- und Jugendmedizin
    • Bayern
      • München, Bayern, Alemanha, 80336
        • Sonnengesundheitszentrum
    • Niedersachsen
      • Hannover, Niedersachsen, Alemanha, 30159
        • Werlhof-Institut für Haemostaseologie GmbH
    • Nordrhein-westfalen
      • Muenster, Nordrhein-westfalen, Alemanha, 48143
        • Institut für Thrombophilie und Hämostaseologie
  • Áustria
      • Linz, Áustria, 4020
        • Allgemeines Krankenhaus Linz, Kinderklinik

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with hemophilia B

Descrição

Inclusion Criteria:

  • Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

  • Patients with hemophilia B treated with a product other than BeneFIX®.
  • Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
A
Patients with Hemophilia B
Medicamento: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Baseline until last visit (up to 8.7 years)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Baseline until last visit (up to 8.7 years)
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Baseline until last visit (up to 8.7 years)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator.
Baseline until last visit (up to 8.7 years)
Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
Prazo: Baseline until last visit (up to 8.7 years)
FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Baseline until last visit (up to 8.7 years)
Number of Participants With Adverse Events (AEs) of Special Interest
Prazo: Baseline until last visit (up to 8.7 years)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.
Baseline until last visit (up to 8.7 years)
Investigator Assessment of Treatment Tolerability of Participants
Prazo: End of study visit (any time up to 8.7 years)
Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)
Participant Assessment of Treatment Tolerability
Prazo: End of study visit (any time up to 8.7 years)
Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean Total Number of Bleeding Episodes in Participants
Prazo: Baseline until last visit (up to 8.7 years)
Participants documented all bleeding episodes in a diary during the study.
Baseline until last visit (up to 8.7 years)
Mean Total Number of Bleeding Episodes Per Year in Participants
Prazo: Baseline until last visit (up to 8.7 years)
Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Baseline until last visit (up to 8.7 years)
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
Prazo: Baseline, up to 8.7 years
Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Baseline, up to 8.7 years
Investigator Assessment of Treatment Efficacy of Participants
Prazo: End of study visit (any time up to 8.7 years)
Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)
Investigator Assessment of Treatment Handling of Participants
Prazo: End of study visit (any time up to 8.7 years)
Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)
Assessment of Treatment Efficacy by the Participants
Prazo: End of study visit (any time up to 8.7 years)
Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)
Assessment of Treatment Handling by the Participants
Prazo: End of study visit (any time up to 8.7 years)
Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
End of study visit (any time up to 8.7 years)
Investigator Assessment of Treatment Satisfaction of Participants
Prazo: Baseline up to 8.7 years
Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
Baseline up to 8.7 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2008

Conclusão Primária (Real)

1 de outubro de 2016

Conclusão do estudo (Real)

1 de outubro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de julho de 2008

Primeira postagem (Estimativa)

14 de julho de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de outubro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de setembro de 2018

Última verificação

1 de setembro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 3090A1-4406
  • B1821011 (Outro identificador: Alias Study Number)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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