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PK/PD of Lipegfilgrastim in Healthy Japanese and Caucasian Subjects
NCT02306915Phase 1Completed
- Sponsor
- Merckle GmbH
- Start
- Oct 2014
- Primary completion
- Mar 2015
- Modality
- Cytokines & Interferons, Carrier/Scaffold Proteins
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of lipegfilgrastim in neutropenia (3 arms), sponsored by Merckle GmbH. Primary endpoints: Area under the serum concentration-time curve from time 0 to the last measurable concentration at Day 21, Area under the serum concentration-time curve extrapolated to infinity at Day 21 and 5 more. Started Oct 2014; status: completed.
02
Drugs
lipegfilgrastim
03
Conditions
neutropenia
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