Study Phase 3

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy

Trial Information

Generic NameEpoetin alfaProduct NamePROCRIT®Therapeutic AreaBlood and Blood-Forming OrgansProduct ClassAntianemic PreparationsPharmacological SubgroupOther Antianemic PreparationsChemical SubgroupOther Antianemic PreparationsCondition StudiedAnemia, Neoplasms, Breast
Sponsor Protocol NumberCR004414 (EPO-INT-76) DOUBLE BLINDEnrollment939Data PartnerJohnson & Johnson% Female100%Mean/Median Age (Years)55.4% White98.0%

Supporting Documentation

  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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