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PROCRIT (Epoetin Alfa) in Anemic Cancer Patients Not on Chemotherapy
NCT00388336Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2004
- Sponsor
- Johnson & Johnson
- Modality
- Biologic, rProtein (Recombinant Protein)
- Drugs
- epoetin alfa
- Conditions
- anemia
01
Overview
Phase 2, open-label, single-arm trial of epoetin alfa in anemia, sponsored by Johnson & Johnson. Primary endpoint: Hematopoietic Response Rate at 12 weeks. Started Feb 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
PROCRIT 60,000 U
Epoetin alfa 60,000 Units SC every 2 weeks
03
Who it enrols
Patients with non-myeloid malignancy and anemia (Hb <= 11 g/dL) not receiving chemotherapy or radiation.
04
Endpoints
Primary
Hematopoietic Response Rate
Secondary
Transfusion Requirements
Quality of Life (LASA, FACT-An)
Time to Hemoglobin Response
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