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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00711958 |
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.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: HX 575 solution for injection (s.c.) Drug: ERYPO®, Janssen-Cilag, Germany. Solution for injection (s.c.) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients |
Enrollment: | 105 |
Study Start Date: | November 2004 |
Study Completion Date: | December 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
HX 575
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Drug: HX 575 solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
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2: Active Comparator
ERYPO® Janssen-Cilag, Germany
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Drug: ERYPO®, Janssen-Cilag, Germany. Solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Robert-Bosch-Krankenhaus | |
Stuttgart, Germany, 70376 | |
Gemeinschaftspraxis Dr.med. Heinrich-Ekkerd Fiechtner | |
Stuttgart, Germany, 70173 | |
Universitätsklinikum Tübingen Medizinische Klinik 1 | |
Tübingen, Germany, 72076 | |
Gemeinschaftspraxis für internistische Onkologie | |
Velbert, Germany, 42551 | |
Praxis für internistische Onkologie | |
Weiden, Germany, 92637 | |
Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie | |
Bad Soden, Germany, 65812 | |
Praxis für Onkologie Dr.med. Siegfried Völkl | |
Munich, Germany, 80637 | |
Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13 | |
Nürnberg, Germany, 90419 | |
Praxis Drs. Kowolik/Prechtl | |
Munich, Germany, 81925 | |
DRK-Krankenhaus | |
Luckenwalde, Germany, 14943 | |
Poliklinik am Paritätischen Krankenhaus | |
Berlin, Germany, 10365 | |
Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie | |
Berlin, Germany, 10367 | |
Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter | |
Augsburg, Germany, 86150 | |
Praxis Drs. Marschner, Zeiss, Kirste | |
Freiburg, Germany, 79106 | |
Oskar-Helene-Heim | |
Berlin, Germany, 14195 | |
Romania | |
County Hospital Satu-Mare | |
Satu-Mare, Romania, 440192 | |
Oncomed SRL Timisoara | |
Timisoara, Romania, 300239 | |
Country hospital Oradea | |
Oradea, Romania, 410032 | |
Oncologic Institute "Prof.Dr.I.Chiricuta" Cluj | |
Cluj-Napoca, Romania, 400015 |
Study Chair: | Andrea Vetter, Dr. | Hexal AG |
Responsible Party: | Hexal AG ( Hexal AG ) |
Study ID Numbers: | 2003-31-INJ-11 |
Study First Received: | July 3, 2008 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00711958 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Romania: National Medicines Agency |
Chemotherapy associated anemia in cancer patients |
Epoetin Alfa Hematologic Diseases Anemia |
Hematologic Diseases Anemia |