Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
This trial is active, not recruiting.
|Condition||hematopoietic stem cell mobilization|
|Start date||May 2011|
|End date||August 2024|
|Trial size||245 participants|
|Trial identifier||NCT01766934, EP06-501|
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Frankfurt/Main, Germany||German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main||no longer recruiting|
|Ulm, Germany||German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)||no longer recruiting|
Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
time frame: each patient will be followed for 10 years after mobilization
Efficacy assessment in terms of the CD34+ cell count.
time frame: CD34+ cells are counted on 1 day immediately preceding apheresis
Male or female participants at least 18 years old.
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.
|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|
|Description||This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization.|
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