drugset / Trial / NCT00210834
An Efficacy and Safety Study of Epoetin Alfa (PROCRIT) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy.
Phase 2
Completed
310 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The secondary objectives of the study are to assess the Hb response, time to Hb response, transfusion requirements, and safety.
Timeline
- Start
- 2004-05
- Primary completion
- —
- Completion
- 2005-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 40000 iu | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 80000 iu | Subcutaneous |