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Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

18 settembre 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

171

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
      • Aschaffenburg, Germania, 63739
        • Office of Manfred Welslau
      • Aschaffenburg, Germania, 63739
        • Office of Martine Klausmann
      • Augsburg, Germania, 86150
        • Office of Bernhard Heinrich
      • Berlin, Germania, 10117
        • Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
      • Berlin, Germania, 13055
        • Office of Reinhard Musch
      • Berlin, Germania, 13595
        • Office of Peter Klare
      • Bochum, Germania, 44787
        • Office of Ute Bückner
      • Chemnitz, Germania, 09117
        • Office of Peter Jungberg
      • Gelsenkirchen, Germania, 45879
        • Office of Ivo Azeh
      • Hannover, Germania, 30449
        • Office of Peter von Wussow
      • Heidenheim, Germania, 89518
        • Office of Volker Petersen
      • Herne, Germania, 44623
        • Office of Lars-Jörgen Hahn
      • Krefeld, Germania, 47804
        • Office of Michael Neise
      • Krefeld, Germania, 47805
        • Office of Gunther Rogmans
      • Kronach, Germania, 96317
        • Office of Peter Anhut
      • Leipzig, Germania, 04103
        • Office of Albrecht Kretzschmar
      • Leipzig, Germania, 04107
        • Office of Nidal Gazawi
      • Mannheim, Germania, 68165
        • Office of Udo Hieber
      • München, Germania, 80638
        • Office of Christoph Salat
      • Münster, Germania, 48149
        • Office of Christian Lerchenmüller
      • Oldenburg, Germania, 26121
        • Office of Burkhard Otremba
      • Osnabrück, Germania, 49076
        • Office of Julian Topaly
      • Rodgau, Germania, 63110
        • Office of Andre-Robert Rotmann
      • Scheibenberg, Germania, 09481
        • Office of Rene Schubert
      • Stolberg, Germania, 52222
        • Office of Matthias Groschek
      • Stralsund, Germania, 18435
        • Office of Carsten Hielscher
      • Stuttgart, Germania, 70193
        • Office of Thomas Kuhn
      • Wiesbaden, Germania, 65191
        • Office of Ortwin Klein

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patients receiving Nivestim
Altro: Overall satisfaction questionnaires of home use of Nivestim

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Any Significant Comorbidities
Lasso di tempo: Baseline (Day 1)
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.
Baseline (Day 1)
Percentage of Participants With Different Types of Haematological Malignancies
Lasso di tempo: Baseline (Day 1)
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.
Baseline (Day 1)
Percentage of Participants With Different Types of Solid Tumour
Lasso di tempo: Baseline (Day 1)
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.
Baseline (Day 1)
Duration of Solid Tumour in Participants Prior to Enrolment in Study
Lasso di tempo: Baseline (Day 1)
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.
Baseline (Day 1)
Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
Lasso di tempo: Baseline (Day 1)
Baseline (Day 1)
Duration of Different Types of Chemotherapies Received by Participants During Study
Lasso di tempo: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants With Response to Study Treatment
Lasso di tempo: Baseline up to 6 months
Baseline up to 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants' Overall Satisfaction Scores in Response to the Study Treatment
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months
Participant's Assessment for Nivestim Packaging
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months
Participant's Assessment of Injection Site Pain and Tolerability
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months
Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months
Percentage of Participants With Neutropenia
Lasso di tempo: Baseline up to 6 months
Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.
Baseline up to 6 months
Percentage of Participants With at Least One Infection and Serious Infection
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months
Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Lasso di tempo: Baseline, Cycle 1, 2, 3, 4, 5, 6
Baseline, Cycle 1, 2, 3, 4, 5, 6
Minimum Value of Absolute Neutrophil Count
Lasso di tempo: Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Lasso di tempo: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Lasso di tempo: Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Lasso di tempo: Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Percentage of Participants With Febrile Neutropenia
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Baseline up to 6 months
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.
Baseline up to 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2015

Completamento primario (Effettivo)

12 dicembre 2016

Completamento dello studio (Effettivo)

12 dicembre 2016

Date di iscrizione allo studio

Primo inviato

3 novembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2016

Primo Inserito (Stima)

6 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ZOB-NIV-1504
  • C1121004 (Altro identificatore: Alias Study Number)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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