Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
18 september 2018 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
171
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Aschaffenburg, Tyskland, 63739
- Office of Manfred Welslau
-
Aschaffenburg, Tyskland, 63739
- Office of Martine Klausmann
-
Augsburg, Tyskland, 86150
- Office of Bernhard Heinrich
-
Berlin, Tyskland, 10117
- Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
-
Berlin, Tyskland, 13055
- Office of Reinhard Musch
-
Berlin, Tyskland, 13595
- Office of Peter Klare
-
Bochum, Tyskland, 44787
- Office of Ute Bückner
-
Chemnitz, Tyskland, 09117
- Office of Peter Jungberg
-
Gelsenkirchen, Tyskland, 45879
- Office of Ivo Azeh
-
Hannover, Tyskland, 30449
- Office of Peter von Wussow
-
Heidenheim, Tyskland, 89518
- Office of Volker Petersen
-
Herne, Tyskland, 44623
- Office of Lars-Jörgen Hahn
-
Krefeld, Tyskland, 47804
- Office of Michael Neise
-
Krefeld, Tyskland, 47805
- Office of Gunther Rogmans
-
Kronach, Tyskland, 96317
- Office of Peter Anhut
-
Leipzig, Tyskland, 04103
- Office of Albrecht Kretzschmar
-
Leipzig, Tyskland, 04107
- Office of Nidal Gazawi
-
Mannheim, Tyskland, 68165
- Office of Udo Hieber
-
München, Tyskland, 80638
- Office of Christoph Salat
-
Münster, Tyskland, 48149
- Office of Christian Lerchenmüller
-
Oldenburg, Tyskland, 26121
- Office of Burkhard Otremba
-
Osnabrück, Tyskland, 49076
- Office of Julian Topaly
-
Rodgau, Tyskland, 63110
- Office of Andre-Robert Rotmann
-
Scheibenberg, Tyskland, 09481
- Office of Rene Schubert
-
Stolberg, Tyskland, 52222
- Office of Matthias Groschek
-
Stralsund, Tyskland, 18435
- Office of Carsten Hielscher
-
Stuttgart, Tyskland, 70193
- Office of Thomas Kuhn
-
Wiesbaden, Tyskland, 65191
- Office of Ortwin Klein
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patients receiving Nivestim
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Any Significant Comorbidities
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline (Day 1)
|
Baseline (Day 1)
|
|
|
Duration of Different Types of Chemotherapies Received by Participants During Study
Tidsram: Baseline up to 6 months
|
Baseline up to 6 months
|
|
|
Percentage of Participants With Response to Study Treatment
Tidsram: Baseline up to 6 months
|
Baseline up to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participants' Overall Satisfaction Scores in Response to the Study Treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, Cycle 1, 2, 3, 4, 5, 6
|
Baseline, Cycle 1, 2, 3, 4, 5, 6
|
|
|
Minimum Value of Absolute Neutrophil Count
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Cycle 1, 2, 3, 4, 5, 6
|
Cycle 1, 2, 3, 4, 5, 6
|
|
|
Percentage of Participants With Febrile Neutropenia
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 september 2015
Primärt slutförande (Faktisk)
12 december 2016
Avslutad studie (Faktisk)
12 december 2016
Studieregistreringsdatum
Först inskickad
3 november 2016
Först inskickad som uppfyllde QC-kriterierna
3 november 2016
Första postat (Uppskatta)
6 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 februari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 september 2018
Senast verifierad
1 september 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ZOB-NIV-1504
- C1121004 (Annan identifierare: Alias Study Number)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .