NCT01766934

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Hematopoietic Stem Cell Mobilization

Timeline

• Start date: 2011-05-01
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2013-01-11
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Germany