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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01766934
First received: January 10, 2013
Last updated: October 2, 2014
Last verified: October 2014

January 10, 2013
October 2, 2014
May 2011
August 2024   (final data collection date for primary outcome measure)
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.
Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim. [ Time Frame: 2011 - 2024 ] [ 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.
Complete list of historical versions of study NCT01766934 on ClinicalTrials.gov Archive Site
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.
Efficacy assessment in terms of the CD34+ cell count. [ Time Frame: 2011 - 2014 ] [ 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.
Not Provided
Not Provided
 
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization

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

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Peripheral Blood Progenitor Cell Mobilization With G-CSF
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2024
August 2024   (final data collection date for primary outcome measure)

Inclusion Criteria:

Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization

Exclusion Criteria:

  • Donors of age <18 years
  • 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 Sandoz' filgrastim
  • Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim
  • Participation in previous stem cell mobilization procedures
  • Previous or concurrent use of other mobilizing agents, e.g. plerixafor
  • Informed consent was not signed prior to beginning of documentation.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01766934
EP06-501
No
Sandoz
Sandoz
Not Provided
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
Sandoz
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP