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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01859637
Other study ID # EP06-401
Secondary ID
Status Terminated
Phase Phase 4
First received May 8, 2013
Last updated November 4, 2015
Start date May 2011
Est. completion date September 2015

Study information

Verified date November 2015
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
Study type Interventional

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.


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Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Eligible patients will be treated with Zarzio®/Filgrastim HEXAL®


Locations

Country Name City State
Germany Medizinischen Hochschule (MHH) Hannover Hannover
Sweden Karolinska Institut Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Sandoz

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity: Incidences of antibodies will be determined Descriptive analyses 12 months Yes
Secondary Safety: to assess the incidence of (S)AEs vital signs, blood chemistry, urinanalysis 12 months Yes
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