drugset
drugset / Trial / NCT01394991

A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia

NCT01394991 ↗

Phase 4 Completed 504 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.

Timeline

Start
2006-01
Primary completion
2009-09
Completion
2009-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Epoetin Alfa QW vs Epoetin Alfa TIW; p = 0.248; Risk Difference (RD) -0.018 (95% CI -0.051 to 0.016); Chi-squared NCT01394991 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 150 iu/kg Subcutaneous
Subject epoetin alfa Protein / enzyme biologic 450 iu/kg Subcutaneous

Indications

anemia neoplasm