Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01766934
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01766934
Study Brief:
Protocol Section:
NCT01766934