Anemia of cancer in subjects who are not receiving chemotherapy MedDRA version: 7.0 Level: PT Classification code 10049105
Conditions
Interventions
Trade Name: Aranesp
Product Name: Aranesp
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who complete the planned 16 weeks of treatment on the 20010103 study 2) Subjects who have given written informed consent Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy ( pelvic/ spinal irradiation) during the study 2) Subjects who have other diagnoses not related to the cancer which can cause anemia (eg gastrointestinal bleeding, renal disease, etc) 3) Cardiac condition: uncontrolled angina, congestive heart failure or known ejection fraction 100 mmHg) 5) Clinically significant systemic infection or chronic inflammatory disease (eg rheumatoid arthritis) present at time of enrollment 6) Subject of reproductive potential not using adequate contraceptive precautions 7) Concerns for subject’s compliance with protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy;Secondary Objective: ;Primary end point(s): Primary safety endpoint: Incidence of adverse events Patient Reported Outcome (PRO) Endpoints: Change in PRO scores from baseline | — |
Countries
Latvia
Outcome results
None listed