This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.
Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased \<1.0 g/dL or the reticulocyte count increased \<40,000 /μl after 4 weeks or if Hb increased \<2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter
Augsburg, Germany
Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie
Bad Soden, Germany
Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia
Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.
Time frame: 5-12 weeks
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Poliklinik am Paritätischen Krankenhaus
Berlin, Germany
Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie
Berlin, Germany
Oskar-Helene-Heim
Berlin, Germany
Praxis Drs. Marschner, Zeiss, Kirste
Freiburg im Breisgau, Germany
DRK-Krankenhaus
Luckenwalde, Germany
Praxis für Onkologie
Munich, Germany
Praxis Drs. Kowolik/Prechtl
Munich, Germany
Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13
Nuremberg, Germany
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