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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

調査の概要

状態

完了

条件

介入・治療

研究の種類

観察的

入学 (実際)

171

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Patients receiving Nivestim
他の：Overall satisfaction questionnaires of home use of Nivestim

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Any Significant Comorbidities
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (Day 1)
Baseline (Day 1)
Duration of Different Types of Chemotherapies Received by Participants During Study
時間枠：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants With Response to Study Treatment
時間枠：Baseline up to 6 months
Baseline up to 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Participants' Overall Satisfaction Scores in Response to the Study Treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Cycle 1, 2, 3, 4, 5, 6
Baseline, Cycle 1, 2, 3, 4, 5, 6
Minimum Value of Absolute Neutrophil Count
時間枠：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
時間枠：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
時間枠：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
時間枠：Cycle 1, 2, 3, 4, 5, 6
Cycle 1, 2, 3, 4, 5, 6
Percentage of Participants With Febrile Neutropenia
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年9月23日

一次修了 (実際)

2016年12月12日

研究の完了 (実際)

2016年12月12日

試験登録日

最初に提出

2016年11月3日

QC基準を満たした最初の提出物

2016年11月3日

最初の投稿 (見積もり)

2016年11月6日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月11日

QC基準を満たした最後の更新が送信されました

2018年9月18日

最終確認日

2018年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ZOB-NIV-1504
  • C1121004 (その他の識別子：Alias Study Number)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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