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Clinical Trial Summary

Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chromic administration.

Study was initiated as a post marketing authorization commitment to European Medicines Agency (EMA). Subsequent submission of long term safety and immunogenicity data from pooled studies and post-marketing experience have addressed the commitment and study no longer necessary to be continued and hence prematurely terminated.

No patients were ongoing in the study at the time of study termination.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01859637
Study type Interventional
Source Sandoz
Contact
Status Terminated
Phase Phase 4
Start date May 2011
Completion date September 2015

See also
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