Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
18 сентября 2018 г. обновлено: 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
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Действительный)
171
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Aschaffenburg, Германия, 63739
- Office of Manfred Welslau
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Aschaffenburg, Германия, 63739
- Office of Martine Klausmann
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Augsburg, Германия, 86150
- Office of Bernhard Heinrich
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Berlin, Германия, 10117
- Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
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Berlin, Германия, 13055
- Office of Reinhard Musch
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Berlin, Германия, 13595
- Office of Peter Klare
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Bochum, Германия, 44787
- Office of Ute Bückner
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Chemnitz, Германия, 09117
- Office of Peter Jungberg
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Gelsenkirchen, Германия, 45879
- Office of Ivo Azeh
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Hannover, Германия, 30449
- Office of Peter von Wussow
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Heidenheim, Германия, 89518
- Office of Volker Petersen
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Herne, Германия, 44623
- Office of Lars-Jörgen Hahn
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Krefeld, Германия, 47804
- Office of Michael Neise
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Krefeld, Германия, 47805
- Office of Gunther Rogmans
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Kronach, Германия, 96317
- Office of Peter Anhut
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Leipzig, Германия, 04103
- Office of Albrecht Kretzschmar
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Leipzig, Германия, 04107
- Office of Nidal Gazawi
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Mannheim, Германия, 68165
- Office of Udo Hieber
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München, Германия, 80638
- Office of Christoph Salat
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Münster, Германия, 48149
- Office of Christian Lerchenmüller
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Oldenburg, Германия, 26121
- Office of Burkhard Otremba
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Osnabrück, Германия, 49076
- Office of Julian Topaly
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Rodgau, Германия, 63110
- Office of Andre-Robert Rotmann
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Scheibenberg, Германия, 09481
- Office of Rene Schubert
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Stolberg, Германия, 52222
- Office of Matthias Groschek
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Stralsund, Германия, 18435
- Office of Carsten Hielscher
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Stuttgart, Германия, 70193
- Office of Thomas Kuhn
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Wiesbaden, Германия, 65191
- Office of Ortwin Klein
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Patients receiving Nivestim
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants With Any Significant Comorbidities
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline up to 6 months
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Baseline up to 6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Participants' Overall Satisfaction Scores in Response to the Study Treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
23 сентября 2015 г.
Первичное завершение (Действительный)
12 декабря 2016 г.
Завершение исследования (Действительный)
12 декабря 2016 г.
Даты регистрации исследования
Первый отправленный
3 ноября 2016 г.
Впервые представлено, что соответствует критериям контроля качества
3 ноября 2016 г.
Первый опубликованный (Оценивать)
6 ноября 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 февраля 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 сентября 2018 г.
Последняя проверка
1 сентября 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ZOB-NIV-1504
- C1121004 (Другой идентификатор: Alias Study Number)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .