Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
2018년 9월 18일 업데이트: 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
연구 개요
상태
완전한
연구 유형
관찰
등록 (실제)
171
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Aschaffenburg, 독일, 63739
- Office of Manfred Welslau
-
Aschaffenburg, 독일, 63739
- Office of Martine Klausmann
-
Augsburg, 독일, 86150
- Office of Bernhard Heinrich
-
Berlin, 독일, 10117
- Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
-
Berlin, 독일, 13055
- Office of Reinhard Musch
-
Berlin, 독일, 13595
- Office of Peter Klare
-
Bochum, 독일, 44787
- Office of Ute Bückner
-
Chemnitz, 독일, 09117
- Office of Peter Jungberg
-
Gelsenkirchen, 독일, 45879
- Office of Ivo Azeh
-
Hannover, 독일, 30449
- Office of Peter von Wussow
-
Heidenheim, 독일, 89518
- Office of Volker Petersen
-
Herne, 독일, 44623
- Office of Lars-Jörgen Hahn
-
Krefeld, 독일, 47804
- Office of Michael Neise
-
Krefeld, 독일, 47805
- Office of Gunther Rogmans
-
Kronach, 독일, 96317
- Office of Peter Anhut
-
Leipzig, 독일, 04103
- Office of Albrecht Kretzschmar
-
Leipzig, 독일, 04107
- Office of Nidal Gazawi
-
Mannheim, 독일, 68165
- Office of Udo Hieber
-
München, 독일, 80638
- Office of Christoph Salat
-
Münster, 독일, 48149
- Office of Christian Lerchenmüller
-
Oldenburg, 독일, 26121
- Office of Burkhard Otremba
-
Osnabrück, 독일, 49076
- Office of Julian Topaly
-
Rodgau, 독일, 63110
- Office of Andre-Robert Rotmann
-
Scheibenberg, 독일, 09481
- Office of Rene Schubert
-
Stolberg, 독일, 52222
- Office of Matthias Groschek
-
Stralsund, 독일, 18435
- Office of Carsten Hielscher
-
Stuttgart, 독일, 70193
- Office of Thomas Kuhn
-
Wiesbaden, 독일, 65191
- Office of Ortwin Klein
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Patients receiving Nivestim
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Any Significant Comorbidities
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline (Day 1)
|
Baseline (Day 1)
|
|
|
Duration of Different Types of Chemotherapies Received by Participants During Study
기간: Baseline up to 6 months
|
Baseline up to 6 months
|
|
|
Percentage of Participants With Response to Study Treatment
기간: Baseline up to 6 months
|
Baseline up to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participants' Overall Satisfaction Scores in Response to the Study Treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, Cycle 1, 2, 3, 4, 5, 6
|
Baseline, Cycle 1, 2, 3, 4, 5, 6
|
|
|
Minimum Value of Absolute Neutrophil Count
기간: 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
기간: 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
기간: 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
기간: Cycle 1, 2, 3, 4, 5, 6
|
Cycle 1, 2, 3, 4, 5, 6
|
|
|
Percentage of Participants With Febrile Neutropenia
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 9월 23일
기본 완료 (실제)
2016년 12월 12일
연구 완료 (실제)
2016년 12월 12일
연구 등록 날짜
최초 제출
2016년 11월 3일
QC 기준을 충족하는 최초 제출
2016년 11월 3일
처음 게시됨 (추정)
2016년 11월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 9월 18일
마지막으로 확인됨
2018년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ZOB-NIV-1504
- C1121004 (기타 식별자: Alias Study Number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .