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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01716559
First received: October 11, 2012
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
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
Anemia

Study Type: Observational
Study Design: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Mean Change From Baseline in Hemoglobin Level up to Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 16 ] [ Designated as safety issue: No ]
    The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.

  • Percentage of Red Blood Cell Transfusion-free Participants [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.

  • Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anemic patients with non-myeloid malignancy
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716559

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01716559     History of Changes
Other Study ID Numbers: ML25362 
Study First Received: October 11, 2012
Results First Received: January 11, 2016
Last Updated: January 11, 2016
Health Authority: Hungary: National Institute of Pharmacy

ClinicalTrials.gov processed this record on May 26, 2016