Trial document




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  DRKS00005282

Trial Description

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Title

Epoetin alfa HEXAL® in oncology and haematology patients with chemotherapy induced anaemia. A noninterventional observational study.

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Trial Acronym

OncoBOS

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URL of the Trial

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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. 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 three to six chemotherapy cycles. Epoetin alfa stimulates the production of red blood cells.
The aims of the study are the description of the management of anaemia with Epoetin alfa HEXAL, the confirmation of the safety profile of Epoetin alfa HEXAL in the examined patient group, an assessment of its effectiveness, the collection of information on Epoetin self-administration and on changes of quality of life, 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

See above

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Organizational Data

  •   DRKS00005282
  •   2013/09/03
  •   [---]*
  •   no
  •   Approved
  •   PV4471, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   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, three 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

Management of anaemia with Epoetin alfa HEXAL: baseline haemoglobin (Hb), changes of Hb, start dose and dose adjustments, achievement of target Hb, duration and temporary discontinuations of therapy, lab parameters of iron metabolism, iron Supplementation; motives for the use of Epoetin; consideration of guidelines.

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Secondary Outcome

Safety profile of Epoetin alfa HEXAL: Blood pressure, haematological and clinical chemistry lab, arterial and/or venous thromboembolic or other cardiovascular events, AEs (adverse events) [per cycle, AEs continuously]. Clinical effectiveness: Haematological and clinical chemistry lab, number of red blood cell transfusions [per cycle]; Epoetin self-application: Adequate patient information, experience, Performance [last cycle]; Change of quality of life: LASA scale (Linear Analogue Scale Assessment) [first and last cycle]; Course of anthracycline induced cardiomyopathy under therapy with Epoetin alfa: LVEF (left ventricular ejection fraction), cardiac troponin, natriuretic peptides [start of chemotherapy line, one further documentation over the study period, as far as routinely determined].

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/10/08
  •   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. Diagnosis of solid tumour, malignant lymphoma or multiple myeloma;
2. Tumour therapy with chemotherapy alone or in combination with other therapies;
3.Therapy with Epoetin alfa HEXAL for symptomatic anaemia and a reduction of transfusions is planned for three to six chemotherapy cycles;
4. 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

1. Patient is treated within another study;
2. Tumour therapy consists of radiation alone;
3. Patient suffers from acute leucaemia or chronic myeloproliferative syndrome;
4. Patient suffers from non-treated haemolytic anaemia or from iron, vitamin B12 or folic acid deficiency anaemia not related to the tumour;
5. Patient has participated in the same study earlier;
6. Contraindications to Epoetin alfa HEXAL according to the current summary of product characteristics.
7. Female patients: Pregnancy or breast-feeding.

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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
    • Germany
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    •   040 7410-52960
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    •   [---]*
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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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* This entry means the parameter is not applicable or has not been set.