Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
18 de setembro de 2018 atualizado por: Pfizer
Home Administration Of Nivestim(tm) In The Primary Prophylaxis Of Chemotherapy- Induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home Short Name: Home
Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Real)
171
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
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Aschaffenburg, Alemanha, 63739
- Office of Manfred Welslau
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Aschaffenburg, Alemanha, 63739
- Office of Martine Klausmann
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Augsburg, Alemanha, 86150
- Office of Bernhard Heinrich
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Berlin, Alemanha, 10117
- Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
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Berlin, Alemanha, 13055
- Office of Reinhard Musch
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Berlin, Alemanha, 13595
- Office of Peter Klare
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Bochum, Alemanha, 44787
- Office of Ute Bückner
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Chemnitz, Alemanha, 09117
- Office of Peter Jungberg
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Gelsenkirchen, Alemanha, 45879
- Office of Ivo Azeh
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Hannover, Alemanha, 30449
- Office of Peter von Wussow
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Heidenheim, Alemanha, 89518
- Office of Volker Petersen
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Herne, Alemanha, 44623
- Office of Lars-Jörgen Hahn
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Krefeld, Alemanha, 47804
- Office of Michael Neise
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Krefeld, Alemanha, 47805
- Office of Gunther Rogmans
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Kronach, Alemanha, 96317
- Office of Peter Anhut
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Leipzig, Alemanha, 04103
- Office of Albrecht Kretzschmar
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Leipzig, Alemanha, 04107
- Office of Nidal Gazawi
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Mannheim, Alemanha, 68165
- Office of Udo Hieber
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München, Alemanha, 80638
- Office of Christoph Salat
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Münster, Alemanha, 48149
- Office of Christian Lerchenmüller
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Oldenburg, Alemanha, 26121
- Office of Burkhard Otremba
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Osnabrück, Alemanha, 49076
- Office of Julian Topaly
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Rodgau, Alemanha, 63110
- Office of Andre-Robert Rotmann
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Scheibenberg, Alemanha, 09481
- Office of Rene Schubert
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Stolberg, Alemanha, 52222
- Office of Matthias Groschek
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Stralsund, Alemanha, 18435
- Office of Carsten Hielscher
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Stuttgart, Alemanha, 70193
- Office of Thomas Kuhn
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Wiesbaden, Alemanha, 65191
- Office of Ortwin Klein
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Adults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.
Descrição
Inclusion Criteria:
- Male and female patients ≥ 18 years
- Declaration of informed consent signed by patient
- Patients with a solid tumour or with a malignant haematological tumour
- Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
- GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
- Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN
Exclusion Criteria:
- Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
- Patients who are hypersensitive to one of the excipients of NivestimTM
- Patients not undergoing chemotherapy
- Patients being treated curatively or as secondary prophylaxis with G-CSF
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 |
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Patients receiving Nivestim
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants With Any Significant Comorbidities
Prazo: Baseline (Day 1)
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Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital).
Percentage of participants with any ongoing comorbidities were reported in this outcome measure.
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Baseline (Day 1)
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Percentage of Participants With Different Types of Haematological Malignancies
Prazo: Baseline (Day 1)
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Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations.
Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.
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Baseline (Day 1)
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Percentage of Participants With Different Types of Solid Tumour
Prazo: Baseline (Day 1)
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Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours.
Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.
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Baseline (Day 1)
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Duration of Solid Tumour in Participants Prior to Enrolment in Study
Prazo: Baseline (Day 1)
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Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.
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Baseline (Day 1)
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Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
Prazo: Baseline (Day 1)
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Baseline (Day 1)
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Duration of Different Types of Chemotherapies Received by Participants During Study
Prazo: Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Participants With Response to Study Treatment
Prazo: Baseline up to 6 months
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Baseline up to 6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participants' Overall Satisfaction Scores in Response to the Study Treatment
Prazo: Baseline up to 6 months
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Participants rated the overall satisfaction with Nivestim as part of a questionnaire.
The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months).
The data from all the three time points was summarized and reported collectively in this outcome measure.
The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment.
For this outcome measure, the within-participant average scores are summarized.
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Baseline up to 6 months
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Participant's Assessment for Nivestim Packaging
Prazo: Baseline up to 6 months
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Participants evaluated the packaging of Nivestim as part of a questionnaire.
The packaging was rated under the 2 available categories as either easy or complicated.
The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months).
The data from all the three time points was summarized and reported collectively in this outcome measure.
For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
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Baseline up to 6 months
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Participant's Assessment of Injection Site Pain and Tolerability
Prazo: Baseline up to 6 months
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Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire.
The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful.
Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months).
The data from all the three time points was summarized and reported collectively in this outcome measure.
For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.
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Baseline up to 6 months
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Prazo: Baseline up to 6 months
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Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire.
The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.
The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months).
The data from all the three time points was summarized and reported collectively in this outcome measure.
For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
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Baseline up to 6 months
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Percentage of Participants With Neutropenia
Prazo: Baseline up to 6 months
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Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9
Neutrophils per Liter were reported in this outcome measure.
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Baseline up to 6 months
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Percentage of Participants With at Least One Infection and Serious Infection
Prazo: Baseline up to 6 months
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Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection.
Serious Infections included serious adverse events 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; congenital anomaly.
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Baseline up to 6 months
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Prazo: Baseline, Cycle 1, 2, 3, 4, 5, 6
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Baseline, Cycle 1, 2, 3, 4, 5, 6
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Minimum Value of Absolute Neutrophil Count
Prazo: Cycle 1, 2, 3, 4, 5, 6
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Cycle 1, 2, 3, 4, 5, 6
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Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Prazo: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
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End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
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Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Prazo: Cycle 1, 2, 3, 4, 5, 6
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Cycle 1, 2, 3, 4, 5, 6
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Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Prazo: Cycle 1, 2, 3, 4, 5, 6
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Cycle 1, 2, 3, 4, 5, 6
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Percentage of Participants With Febrile Neutropenia
Prazo: Baseline up to 6 months
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Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and absolute neutrophil count of less than (<) 1.0 × 10^9 Neutrophils per Liter.
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Baseline up to 6 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Baseline up to 6 months
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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 6 months that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious.
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Baseline up to 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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)
23 de setembro de 2015
Conclusão Primária (Real)
12 de dezembro de 2016
Conclusão do estudo (Real)
12 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
3 de novembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de novembro de 2016
Primeira postagem (Estimativa)
6 de novembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de setembro de 2018
Última verificação
1 de setembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZOB-NIV-1504
- C1121004 (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 .