A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
- Registration Number
- NCT00115167
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 371
Inclusion Criteria
- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
Exclusion Criteria
- Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
- Subjects who have other diagnoses not related to the cancer which can cause anemia
- Known history of seizure disorder
- Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
- Subject of reproductive potential who is not using adequate contraceptive precautions
- Concerns for subject's compliance with the protocol procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Darbepoetin alfa Darbepoetin alfa -
- Primary Outcome Measures
Name Time Method Incidence of adverse events throughout study
- Secondary Outcome Measures
Name Time Method Confirmed antibody formation to investigational product throughout study Deaths on study on study Laboratory parameters throughout study Vital signs (blood pressure) throughout study Change in PRO scores from baseline to end of treatment