drugset / Trial / NCT02044276

A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia

NCT02044276

Phase 3 Completed 101 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.

Timeline

Start
2014-03-31
Primary completion
2017-08-29
Completion
2018-04-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Subject lipegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous