An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
NCT ID: NCT01809314
Last Updated: 2016-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
1167 participants
OBSERVATIONAL
2008-03-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NeoRecormon in Symptomatic Anemia
Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study.
Epoetin beta
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
Interventions
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Epoetin beta
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with solid tumors or lymphoproliferative disease
* Participants receiving chemotherapy
* Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (\<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
* ECOG performance status of 0, 1, or 2
Exclusion Criteria
* Acute chronic bleeding within 3 months prior to study
* Iron deficiency that is unmanageable prior to study
* Hypersensitivity to the active substance or any of the excipients of the product
* Pregnant or breastfeeding women
* Epoetin treatment within 6 months prior to study
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Deszk, , Hungary
Dunaújváros, , Hungary
Eger, , Hungary
Farkasgyepű, , Hungary
Győr, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Miskolc, , Hungary
Mosdós, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Pécs, , Hungary
Pécs, , Hungary
Salgótarján, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Tatabánya, , Hungary
Törökbálint, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Countries
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Other Identifiers
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ML21420
Identifier Type: -
Identifier Source: org_study_id
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