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

2018年9月18日 更新者：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

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

171

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Patients receiving Nivestim
其他：Overall satisfaction questionnaires of home use of Nivestim

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With Any Significant Comorbidities
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline (Day 1)
Baseline (Day 1)
Duration of Different Types of Chemotherapies Received by Participants During Study
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants With Response to Study Treatment
大体时间：Baseline up to 6 months
Baseline up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Participants' Overall Satisfaction Scores in Response to the Study Treatment
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline, Cycle 1, 2, 3, 4, 5, 6
Baseline, Cycle 1, 2, 3, 4, 5, 6
Minimum Value of Absolute Neutrophil Count
大体时间：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
大体时间：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
大体时间：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
大体时间：Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Percentage of Participants With Febrile Neutropenia
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月23日

初级完成 (实际的)

2016年12月12日

研究完成 (实际的)

2016年12月12日

研究注册日期

首次提交

2016年11月3日

首先提交符合 QC 标准的

2016年11月3日

首次发布 (估计)

2016年11月6日

研究记录更新

最后更新发布 (实际的)

2019年2月11日

上次提交的符合 QC 标准的更新

2018年9月18日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ZOB-NIV-1504
  • C1121004 (其他标识符：Alias Study Number)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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