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

18. September 2018 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

171

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Patients receiving Nivestim
Sonstiges: Overall satisfaction questionnaires of home use of Nivestim

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Any Significant Comorbidities
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline (Day 1)
Baseline (Day 1)
Duration of Different Types of Chemotherapies Received by Participants During Study
Zeitfenster: Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants With Response to Study Treatment
Zeitfenster: Baseline up to 6 months
Baseline up to 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participants' Overall Satisfaction Scores in Response to the Study Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, Cycle 1, 2, 3, 4, 5, 6
Baseline, Cycle 1, 2, 3, 4, 5, 6
Minimum Value of Absolute Neutrophil Count
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Percentage of Participants With Febrile Neutropenia
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. September 2015

Primärer Abschluss (Tatsächlich)

12. Dezember 2016

Studienabschluss (Tatsächlich)

12. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

3. November 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2016

Zuerst gepostet (Schätzen)

6. November 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Februar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ZOB-NIV-1504
  • C1121004 (Andere Kennung: Alias Study Number)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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