Status:
COMPLETED
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
Lead Sponsor:
Amgen
Conditions:
Anemia
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- \- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00115167
Start Date
August 1 2004
End Date
March 1 2007
Last Update
May 11 2009
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