Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
NCT ID: NCT02140736
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2333 participants
OBSERVATIONAL
2009-09-30
2011-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
NCT01374373
Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
NCT00148421
Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
NCT00270127
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
NCT00211133
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
NCT00270166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with chemo-induced symptomatic anemia
Epoetin biosimilar
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epoetin biosimilar
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients presenting with anemia following chemotherapy
* Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy
\-- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
* Patients eligible for epoetin alfa biosimilar treatment
Exclusion Criteria
* Patients already included in an epoetin zeta trial
* Patients presenting with a contraindication to epoetin zeta
* Patients presenting with hypersensitivity to the active principle or any of the excipients
* Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
* Patient with uncontrollable arterial hypertension
* Patients who cannot receive adequate prophylaxis by antithrombotic agents
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Agen, , France
Aix-en-Provence, , France
Aix-en-Provence, , France
Aix-en-Provence, , France
Ajaccio, , France
Albi, , France
Amboise, , France
Amilly, , France
Annecy, , France
Antibes, , France
Armentières, , France
Arras, , France
Arras, , France
Aulnay-sous-Bois, , France
Avignon, , France
Avignon, , France
Bayonne, , France
Beauvais, , France
Besançon, , France
Beuvry, , France
Béthune, , France
Béziers, , France
Blois, , France
Bois-Guillaume, , France
Bordeaux, , France
Bordeaux, , France
Bordeaux, , France
Boulogne-sur-Mer, , France
Brest, , France
Brest, , France
Bron, , France
Caen, , France
Caen, , France
Cannes, , France
Cannes, , France
Carcassonne, , France
Carcassonne, , France
Castelnau-le-Lez, , France
Challes-les-Eaux, , France
Chalon/saonne, , France
Chambéry, , France
Chambéry, , France
Cherbourg-octeville, , France
Clermont-Ferrand, , France
Colmar, , France
Colmar, , France
Compiègne, , France
Créteil, , France
Croix, , France
Désertines, , France
Dijon, , France
Draguignan, , France
Draguignan, , France
Dunkirk, , France
Évreux, , France
Feurs, , France
Foix, , France
Freyming-Merlebach, , France
Fréjus, , France
Fréjus, , France
Fryming Merle BACH, , France
Gap, , France
Gap, , France
Grasse, , France
Haguenau, , France
Hyères, , France
Hyères, , France
La Roche-sur-Yon, , France
La Rochelle, , France
La Seyne-sur-Mer, , France
La Tronche, , France
Le Blanc-Mesnil, , France
Le Mans, , France
Lille, , France
Lille, , France
Limoges, , France
Lyon, , France
Lyon, , France
Lyon, , France
Lyon, , France
Lyon, , France
Mareuil LES MAUX, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Mâcon, , France
Meaux, , France
Metz, , France
Metz, , France
Monaco, , France
Mont-de-Marsan, , France
Montargis, , France
Montauban, , France
Montbéliard, , France
Montbéliard, , France
Montfermeil, , France
Montpellier, , France
Montpellier, , France
Morlaix, , France
Moulins, , France
Mulhouse, , France
Mulhouse, , France
Mulhouse, , France
Nancy, , France
Nantes, , France
Nantes Saint Herblain, , France
Narbonne, , France
Nice, , France
Nice, , France
Nice, , France
Niort, , France
Nîmes, , France
Nîmes, , France
Nogent/Marne, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Perpignan, , France
Pessac, , France
Pierre-Bénite, , France
Poitiers, , France
Pontoise, , France
Pringy, , France
Pringy, , France
Reims, , France
Rennes, , France
Rouen, , France
Rouen, , France
Rouen, , France
Saint-Cloud, , France
Saint-Gaudens, , France
Saint-Germain-en-Laye, , France
Saint-Germain-en-Laye, , France
Saint-Herblain, , France
Saint-Priest-en-Jarez, , France
Saint-Quentin, , France
Sainte-Feyre, , France
Sélestat, , France
Strasbourg, , France
Strasbourg, , France
Strasbourg, , France
Strasbourg, , France
Strasbourg, , France
Talence, , France
Tarbes, , France
Thionville, , France
Thonon-les-Bains, , France
Toulon, , France
Toulon, , France
Toulon, , France
Toulouse, , France
Toulouse, , France
Tours, , France
Tremblay-en-France, , France
Troyes, , France
Valence, , France
Vandœuvre-lès-Nancy, , France
Versailles, , France
Vénissieux, , France
Vichy, , France
Villefranche/saone, , France
Villeneuve-sur-Lot, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09.214
Identifier Type: OTHER
Identifier Source: secondary_id
1_09.04.2009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.