Trial document




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  DRKS00005121

Trial Description

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Title

Filgrastim Treatment Patterns, Antibiotics Resistance, Chemotherapy Intensity and Efficacy for preventing Neutropenias. A non-interventional study.

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Trial Acronym

FITPATIENT

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URL of the Trial

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Brief Summary in Lay Language

The study documents the routine treatment of patients receiving chemotherapy for a malignant tumour and who are treated with Filgrastim HEXAL for the purpose of shortening the accompanying decrease of white blood cells (neutrophils) and the duration of fever (febrile neutropenia). Filgrastim stimulates the formation of certain white blood cells.
Study aims: Confirmation of the clinical effectiveness and safety profile of Filgrastim HEXAL; examination of the influence filgrastim treatment patterns possess on effectiveness, dose of chemotherapy, frequency of use of antibiotics and of antibiotics resistance; verify a model published in literature (Jenkins et al.) predicting the risk of (febrile) neutropenia based on certain blood values before chemotherapy.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005121
  •   2013/07/01
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  •   no
  •   Approved
  •   053/13, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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Health Condition or Problem studied

  •   D70.1 -  [generalization D70: Agranulocytosis]
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Interventions/Observational Groups

  •   Filgrastim HEXAL is used following the instructions in Ch. 4.2 of the summary of product characteristics. The study documents routinely collected clinical data and laboratory values over six chemotherapy cycles.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Clinical effectiveness of Filgrastim HEXAL: incidence of febrile neutropenia, duration and severity of leucopenia and neutropenia, relative dose intensity of chemotherapy achieved.
Safety Profile of Filgrastim HEXAL: ADRs.

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Secondary Outcome

Antibiotics: incidence and intention of antibiotics therapy, incidence of antibiotics resistance.
Model of Jenkins for predicing risk of (febrile) neutropenia: baseline neutrophils and lymphocytes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/07/10
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients treated with cytotoxic CT for malignant disease and receiving Filgrastim HEXAL according to SmPC; treatment with Filgrastim HEXAL anticipated over two to six CT cycles; written informed consent of patients available covering pro- and retrospective pseudonymised documentation, transmission and analysis of data as well as inspection of data during monitoring.

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Exclusion Criteria

Therapy with another filgrastim during the current CT line; contraindications or specific risks of Filgrastim therapy; earlier participation in the study; pregnancy or breast-feeding; anticipated lack of compliance.

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Addresses

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    • Hexal AG
    • Industriestraße 25
    • 83607  Holzkirchen
    • Germany
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    • Klinik für Onkologie, Hämatologie und Stammzelltransplantation (Med. Klinik IV) – Universitätsklinikum Aachen
    • Mr.  PD Dr. med.  Edgar  Jost 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Hexal AG
    • Mr.  Dr.  Dietmar  Bulenda 
    • Industriestraße 25
    • 83607  Holzkirchen
    • Germany
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    • Hexal AG
    • Mr.  Dr.  Dietmar  Bulenda 
    • Industriestraße 25
    • 83607  Holzkirchen
    • Germany
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Sources of Monetary or Material Support

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    • Hexal AG
    • Industriestraße 25
    • 83607  Holzkirchen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/03/31
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Trial Publications, Results and other Documents

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