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
Information provided by (Responsible Party):
First received: January 10, 2013
Last updated: January 16, 2013
Last verified: January 2013
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
Peripheral Blood Progenitor Cell Mobilization With G-CSF
|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:
U.S. FDA Resources
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.
|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)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766934
|Contact: Sandoz||+49 8024 476 ext 0|
|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
|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|