An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy
1 other identifier
observational
1,167
1 country
42
Brief Summary
This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedResults Posted
Study results publicly available
August 19, 2016
CompletedAugust 19, 2016
June 1, 2016
1.6 years
March 8, 2013
July 8, 2016
July 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).
Baseline, Month 4
Secondary Outcomes (2)
Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline, Month 4
Percentage of Participants Who Required Blood Transfusions During the Study
Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4
Study Arms (1)
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.
Interventions
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
Eligibility Criteria
Participants with symptomatic anemia due to malignancies will be included.
You may qualify if:
- Adults greater than or equal to (≥) 18 years of age
- 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
You may not qualify if:
- Resistant hypertension
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Budapest, 1031, Hungary
Unknown Facility
Budapest, 1076, Hungary
Unknown Facility
Budapest, 1082, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1085, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1106, Hungary
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Budapest, 1145, Hungary
Unknown Facility
Budapest, 1529, Hungary
Unknown Facility
Debrecen, 4012, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Debrecen, H-4031, Hungary
Unknown Facility
Deszk, 6772, Hungary
Unknown Facility
Dunaújváros, 2400, Hungary
Unknown Facility
Eger, 3300, Hungary
Unknown Facility
Farkasgyepű, 8582, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Miskolc, 3501, Hungary
Unknown Facility
Miskolc, 3529, Hungary
Unknown Facility
Mosdós, 7257, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Pécs, 7623, Hungary
Unknown Facility
Pécs, 7624, Hungary
Unknown Facility
Pécs, 7635, Hungary
Unknown Facility
Salgótarján, 3100, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Szekszárd, 7100, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Székesfehérvár, 8001, Hungary
Unknown Facility
Szolnok, 5004, Hungary
Unknown Facility
Szolnok, 5007, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Törökbálint, 2045, Hungary
Unknown Facility
Veszprém, 8200, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 12, 2013
Study Start
March 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 19, 2016
Results First Posted
August 19, 2016
Record last verified: 2016-06