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: April 7, 2014
Last verified: April 2014
  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

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
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: April 7, 2014
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014