Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors

This study is currently recruiting participants.
Verified January 2013 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01766934
First received: January 10, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.


Condition
Peripheral Blood Progenitor Cell Mobilization With G-CSF

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim. [ Time Frame: each patient will be followed for 10 years after mobilization ] [ Designated as safety issue: No ]
    The primary objective is to investigate adverse events that are suspected to be related to stem cell mobilization with the Sandoz' filgrastim in healthy unrelated donors.


Secondary Outcome Measures:
  • Efficacy assessment in terms of the CD34+ cell count. [ Time Frame: CD34+ cells are counted on 1 day immediately preceding apheresis ] [ Designated as safety issue: No ]
    The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count.


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim

Criteria

Inclusion Criteria:

  • none

Exclusion Criteria:

  • Related to recipient
  • Chronic significant organ diseases
  • Systemic autoimmune diseases
  • Chronic infectious diseases
  • History of malignant disease
  • Pregnant and breastfeeding women
  • Hypersensitivity to E. coli derived proteins
  • Hypersensitivity to the active substance or to any of the excipients of the Sandoz' filgrastim
  • Absolute and relative contraindications as specified in the summary of product characteristics of the Sandoz` filgrastim
  • Participation in previous stem cell mobilization procedures
  • Previous or concurrent use of other mobilising agents, e.g. plerixafor
  • Donor is unwilling to give written informed consent to his/her study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766934

Contacts
Contact: Sandoz +49 8024 476 ext 0

Locations
Germany
German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen Recruiting
Frankfurt/Main, Hessen, Germany, 60528
Contact: Halvard Bönig, Dr.med. M.A., MD         
Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Halvard Bönig, Dr. med, M.A., MD Blood Donor Service Baden-Wuerttemberg Hessen
Study Chair: Halvard Bönig, Dr. med. M.A., MD Blood Donor Service Baden-Wuerttemberg Hessen
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01766934     History of Changes
Other Study ID Numbers: EP06-501
Study First Received: January 10, 2013
Last Updated: January 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sandoz:
Peripheral blood progenitor cell (PBPC) mobilization
allogenic hematopoetic stem cell transplantation (HSCT)
recombinant human granulocyte colony stimulating factor (rhG-CSF)
filgrastim

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014