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Non-Interventional StudyNCT02956967

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

An observational study of Non-Interventional Study, run by Pfizer at 28 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Interventional Study
What is being tested?
Overall satisfaction questionnaires of home use of Nivestim
How many people
171 participants
Where
28 sitesGermany
Study dates
23 Sep 2015to 12 Dec 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Germany28 sites

  • Office of Manfred Welslau

    Aschaffenburg, 63739

  • Office of Martine Klausmann

    Aschaffenburg, 63739

  • Office of Bernhard Heinrich

    Augsburg, 86150

  • Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie

    Berlin, 10117

  • Office of Reinhard Musch

    Berlin, 13055

  • Office of Peter Klare

    Berlin, 13595

  • Office of Ute Bückner

    Bochum, 44787

  • Office of Peter Jungberg

    Chemnitz, 09117

  • Office of Ivo Azeh

    Gelsenkirchen, 45879

  • Office of Peter von Wussow

    Hanover, 30449

  • Office of Volker Petersen

    Heidenheim, 89518

  • Office of Lars-Jörgen Hahn

    Herne, 44623

  • Office of Michael Neise

    Krefeld, 47804

  • Office of Gunther Rogmans

    Krefeld, 47805

  • Office of Peter Anhut

    Kronach, 96317

  • Office of Albrecht Kretzschmar

    Leipzig, 04103

  • Office of Nidal Gazawi

    Leipzig, 04107

  • Office of Udo Hieber

    Mannheim, 68165

  • Office of Christoph Salat

    München, 80638

  • Office of Christian Lerchenmüller

    Münster, 48149

  • Office of Burkhard Otremba

    Oldenburg, 26121

  • Office of Julian Topaly

    Osnabrück, 49076

  • Office of Andre-Robert Rotmann

    Rodgau, 63110

  • Office of Rene Schubert

    Scheibenberg, 09481

  • Office of Matthias Groschek

    Stolberg, 52222

  • Office of Carsten Hielscher

    Stralsund, 18435

  • Office of Thomas Kuhn

    Stuttgart, 70193

  • Office of Ortwin Klein

    Wiesbaden, 65191

Other trials in Germany

About this study

Official title: 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

Being tested
Overall satisfaction questionnaires of home use of Nivestim
Keywords
Non-Interventional Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Overall satisfaction questionnaires of home use of NivestimOther

Study groups in NCT02956967
Study groupRoleWhat they receive
Patients receiving NivestimNot described
Receives: Other: Overall satisfaction questionnaires of home use of Nivestim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Any Significant Comorbidities

    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.

    Measured: Baseline (Day 1)

  2. Percentage of Participants With Different Types of Haematological Malignancies

    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.

    Measured: Baseline (Day 1)

  3. Percentage of Participants With Different Types of Solid Tumour

    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.

    Measured: Baseline (Day 1)

  4. Duration of Solid Tumour in Participants Prior to Enrolment in Study

    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.

    Measured: Baseline (Day 1)

  5. Number of Participants Who Received Chemotherapy Prior to Enrolment in Study

    Measured: Baseline (Day 1)

  6. Duration of Different Types of Chemotherapies Received by Participants During Study

    Measured: Baseline up to 6 months

  7. Percentage of Participants With Response to Study Treatment

    Measured: Baseline up to 6 months

Secondary outcomes (12)

  1. Participants' Overall Satisfaction Scores in Response to the Study Treatment

    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.

    Measured: Baseline up to 6 months

  2. Participant's Assessment for Nivestim Packaging

    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.

    Measured: Baseline up to 6 months

  3. Participant's Assessment of Injection Site Pain and Tolerability

    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.

    Measured: Baseline up to 6 months

  4. Participant's Assessment of Overall Tolerability of Subcutaneous Injection

    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.

    Measured: Baseline up to 6 months

  5. Percentage of Participants With Neutropenia

    Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.

    Measured: Baseline up to 6 months

  6. Percentage of Participants With at Least One Infection and Serious Infection

    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.

    Measured: Baseline up to 6 months

  7. Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6

    Measured: Baseline, Cycle 1, 2, 3, 4, 5, 6

  8. Minimum Value of Absolute Neutrophil Count

    Measured: Cycle 1, 2, 3, 4, 5, 6

  9. Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle

    Measured: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)

  10. Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count

    Measured: Cycle 1, 2, 3, 4, 5, 6

  11. Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count

    Measured: Cycle 1, 2, 3, 4, 5, 6

  12. Percentage of Participants With Febrile Neutropenia

    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.

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study start23 Sep 2015
  3. Primary completion12 Dec 2016
  4. Study completion12 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02956967
Sponsor's protocol ID
ZOB-NIV-1504
Other IDs
C1121004
Status last verified
Sep 2018
First submitted
3 Nov 2016
Last updated
11 Feb 2019
Data monitoring committee
No

Publications

  • Otremba B, Hielscher C, Petersen V, Petrik C. Home administration of filgrastim (Nivestim) in primary prophylaxis of chemotherapy-induced febrile neutropenia. Patient Prefer Adherence. 2018 Oct 16;12:2179-2186. doi: 10.2147/PPA.S168029. eCollection 2018.

    PubMed 30410313

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Interventional Study, run by Pfizer at 28 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Any Significant Comorbidities (time frame: Baseline (Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02956967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.

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