NCT02093741

ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

ADVATE 2 mL (Reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

Conditions

• Hemophilia A
• Congenital Factor VIII (FVIII) Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]	The investigators shall determine all treatment regimens according to product labeling information and standard practice.

Timeline

• Start date: 2013-09-20
• Primary completion: 2016-01-20
• Completion: 2016-01-20
• First posted: 2014-03-21
• Last updated: 2021-03-17

Locations

17 sites across 4 countries: France, Germany, Hungary, United Kingdom