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An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809314
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Anemia Drug: Epoetin beta

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Study Type : Observational
Actual Enrollment : 1167 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy
Study Start Date : March 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
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.
Drug: Epoetin beta
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
Other Name: NeoRecormon




Primary Outcome Measures :
  1. Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) [ Time Frame: Baseline, Month 4 ]
    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).


Secondary Outcome Measures :
  1. Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT [ Time Frame: Baseline, Month 4 ]
    ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as "Baseline 0, EOT 2". Transition to a lower performance status indicates improved/increased independence.

  2. Percentage of Participants Who Required Blood Transfusions During the Study [ Time Frame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 ]
    The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with symptomatic anemia due to malignancies will be included.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809314


Locations
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Hungary
Budapest, Hungary, 1031
Budapest, Hungary, 1076
Budapest, Hungary, 1082
Budapest, Hungary, 1083
Budapest, Hungary, 1085
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Budapest, Hungary, 1106
Budapest, Hungary, 1122
Budapest, Hungary, 1125
Budapest, Hungary, 1145
Budapest, Hungary, 1529
Debrecen, Hungary, 4012
Debrecen, Hungary, 4032
Debrecen, Hungary, H-4031
Deszk, Hungary, 6772
Dunaujvaros, Hungary, 2400
Eger, Hungary, 3300
Farkasgyepu, Hungary, 8582
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3501
Miskolc, Hungary, 3529
Mosdos, Hungary, 7257
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7623
Pecs, Hungary, 7624
Pecs, Hungary, 7635
Salgótarján, Hungary, 3100
Szeged, Hungary, 6720
Szekesfehervar, Hungary, 8000
Szekesfehervar, Hungary, 8001
Szekszard, Hungary, 7100
Szolnok, Hungary, 5004
Szolnok, Hungary, 5007
Szombathely, Hungary, 9700
Székesfehérvár, Hungary, 8000
Tatabánya, Hungary, 2800
Torokbalint, Hungary, 2045
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01809314     History of Changes
Other Study ID Numbers: ML21420
First Posted: March 12, 2013    Key Record Dates
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics