drugset / Trial / NCT00317902

An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)

NCT00317902

Phase 4 Completed 292 enrolled Ortho Biotech Products, L.P.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of this study was to treat anemic (Hemoglobin (Hb) \< 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of \> 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.

Timeline

Start
2002-10
Primary completion
Completion
2004-05

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 40000 iu Subcutaneous
Subject epoetin alfa Protein / enzyme biologic 60000 iu Subcutaneous