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Immunogenicity and PD of Biosimilar Pegfilgrastim (Pelmeg) vs Neulasta in Healthy Volunteers
NCT02912377Phase 1Completed
- Sponsor
- Cinfa Biotech
- Start
- Sep 2016
- Primary completion
- May 2017
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of pegfilgrastim in neutropenia (2 arms), sponsored by Cinfa Biotech. Primary endpoints: Incidence of anti-drug antibodies at 6 weeks and Absolute Neutrophil Count at 6 weeks. Started Sep 2016; status: completed.
02
Drugs
pegfilgrastim
03
Conditions
neutropenia
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