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Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure

NCT03323541 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2018-09-21

No results posted yet for this study

Summary

There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.

Conditions

Interventions

DRUG

Filgrastim Prefilled Syringe [Zarzio®]

Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils \>1 giga/l)

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • IANOTTO Jean-Christophe, MD, PhD · Hématologie Clinique-Institut de Cancéro-Hématologie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323541 on ClinicalTrials.gov