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: July 7, 2014
Last verified: July 2014
  Purpose

This observational, prospective, multicenter study will evaluate the treatment r esponse rate and the safety of NeoRecormon (epoetin beta) in anemic patients wit h non-myeloid malignancy. In addition to NeoRecormon, patients receive chemother apy 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate: Change in HB level [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hemoglobin level [ Time Frame: From baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who have not received transfusion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Assessment of the iron status in blood after 16 weeks of NeoRecormon treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety (Incidence of adverse events) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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, 1441
Budapest, Hungary, 1125
Budapest, Hungary, 1088
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01716559     History of Changes
Other Study ID Numbers: ML25362
Study First Received: October 11, 2012
Last Updated: July 7, 2014
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014