An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

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. Identifier: NCT01716559
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : February 9, 2016
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.

Condition or disease

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy
Study Start Date : August 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012


Primary Outcome Measures :
  1. Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8 [ Time Frame: Baseline to Week 8 ]
    Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.

Secondary Outcome Measures :
  1. Mean Change From Baseline in Hemoglobin Level up to Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 16 ]
    The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.

  2. Percentage of Red Blood Cell Transfusion-free Participants [ Time Frame: Up to Week 16 ]
    Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.

  3. Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy [ Time Frame: Up to Week 16 ]
    Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as "1" denotes an effect on the response of treatment with or without iron replacement therapy. Response value as "0" denotes no effect on the response of treatment with or without iron replacement therapy.

  4. Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 16 ]
    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anemic patients with non-myeloid malignancy

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Presence of solid-tumor or non-myeloid malignancy
  • Patients receiving chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Patients require NeoRecormon

Exclusion Criteria:

  • Hypersensitivity to the drug
  • Uncontrolled hypertension
  • Female patients if pregnant and/or lactating

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 identifier (NCT number): NCT01716559

Budapest, Hungary, 1088
Budapest, Hungary, 1125
Budapest, Hungary, 1441
Budapest, Hungary, 1529
Kaposvár, Hungary, 7400
Szolnok, Hungary, 5000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01716559     History of Changes
Other Study ID Numbers: ML25362
First Posted: October 30, 2012    Key Record Dates
Results First Posted: February 9, 2016
Last Update Posted: August 18, 2016
Last Verified: August 2016