Treatment for Patients Suffering From Anemia Due to Chemotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00120692
• Date of registration: 30/06/2005
• Primary sponsor: Amgen
• Public title: Treatment for Patients Suffering From Anemia Due to Chemotherapy
• Scientific title: An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
• Date of first enrolment: October 2002
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00120692
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to
chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or
equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky
Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate
liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known
positive test for human immunodeficiency virus (HIV) infection



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Anemia

Breast Cancer

Intervention(s)

Drug: Darbepoetin Alfa

Drug: Recombinant Human Erythropoietin

Primary Outcome(s)

Anemia correction

Secondary Outcome(s)

Activities of daily living, patient preference

Secondary ID(s)

20020152

Source(s) of Monetary Support

Please refer to primary and secondary sponsors