Trial document




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  DRKS00004219

Trial Description

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Title

Epoetin alfa HEXAL® in Chemotherapy induced Anaemia and Evolution of Cardiomyopathy under Anthracyclines - A non-interventional study

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Trial Acronym

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URL of the Trial

http:///

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Brief Summary in Lay Language

The study documents the routine therapy of tumour patients, who suffer from anaemia induced by chemotherapy, which is based on the drug group called anthracyclines. Only patients will be documented who have an indication for being treated with Epoetin alfa for an amelioration of anaemia symptoms and who are intended to receive Epoetin alfa for two to six chemotherapy cycles. Epoetin alfa stimulates the production of red blood cells.
The aims of the study are the confirmation of the safety profile of Epoetin alfa HEXAL in the examined patient group, an assessment of its effectiveness and the collection of information on the course of anthracycline induced cardiomyopathy under therapy with Epoetin alfa. Cardiomyopathy is a typical side effect of anthracyclines, which appears especially after high total doses. Cardiomyopathy is a sort of heart weakness and its clinical signs include dyspnoea, reduced excercise capacity and water retention/oedema.
The study documents routinely collected clinical and laboratory data from six chemotherapy cycles.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004219
  •   2012/06/29
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  •   no
  •   Approved
  •   PV4065, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   Chemotherapy induced anaemia under anthracycline therapy
  •   D61.10 -  [generalization D61.1: Drug-induced aplastic anaemia]
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Interventions/Observational Groups

  •   Epoetin alfa HEXAL is dosed and injected subcutaneously according to the instructions in the summary of product characteristics one to three times per week under close monitoring of the haemoglobin concentration and/or reticulocyte count. The haemoglobin target range is 10–12 g/dl (6.2–7.5 mmol/l).The study documents routinely collected clinical and laboratory data from six chemotherapy cycles, 2 to six of these cycles should be supported by Epoetin.
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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

Safety profile of Epoetin alfa HEXAL, if used for the treatment of chemotherapy (anthracycline) induced anaemia: Blood pressure, haematological laboratory, arterial and/or venous thromboembolic or other cardiovascular events, ADRs (adverse drug reactions) - Documentation over six chemotherapy cycles.
Generally the data determined at the start of a cycle and the latest data in a cycle will be documented. Arterial and/or venous thromboembolic or other cardiovascular events and ADRs will be documented irrespective of the time of their appearance.

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Secondary Outcome

Clinical effectiveness of Epoetin alfa HEXAL: Haematological laboratory, doses of Epoetin alfa, number of red blood cell transfusions; Course of anthracycline induced cardiomyopathy under therapy with Epoetin alfa: LVEF, cardiac troponin, natriuretic peptides (as far as routinely evaluated); Epoetin self-application (first cycle): Adequate patient information, experience, performance, symptoms, compliance; Change of quality of life (first and last cycle): LASA scale (Linear Analogue Scale Assessment).
Generally the data determined at the start of a cycle and the latest data in a cycle will be documented. All data from examinations not performed routinely (e.g. LVEF) will be documented irrespective of the date of their performance.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/08/29
  •   400
  •   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

1. Male or female patients at least 18 years old with solid tumours, malignant lymphomas or multiple myeloma, who are treated with an anthracycline containing chemotherapy, have not yet received epoetins in the current chemotherapy line and receive Epoetin alfa HEXAL for the first time in this chemotherapy line for symptomatic anaemia.
2. Therapy with Epoetin alfa HEXAL is planned for two to six chemotherapy cycles.
3. Echocardiography with quantitative assessment of LVEF (in %) has been performed at the start of anthracycline based chemotherapy.
4. At least one further echocardiography with quantitative assessment of LVEF (in %) is planned over the patient's further study participation.
5. Data from cycles with anthracycline containing chemotherapy before the start of epoetin treatment are available for retrospective documentation.
6. Written informed consent of patient covering the retro- and prospective pseudonymous documentation, transmission and analysis of data is available.

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Exclusion Criteria

1. Contraindications to Epoetin alfa HEXAL according to the current summary of product characteristics.
2. Patient has not signed the written informed consent form.
3. Patient has participated in the same study earlier.
4. Patient is female and pregnant or breast-feeding.
5. Physician judges the patient as insufficiently compliant.

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Addresses

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    • HEXAL AG
    • Industriestraße 25
    • 83607  Holzkirchen
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf II. Medizinische Klinik und Poliklinik
    • Mr.  Prof. Dr. med.  Carsten  Bokemeyer 
    • Martinistraße 52
    • 20246  Hamburg
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    •   040 7410-52960
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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 stopped after recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.