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ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

Hemophilia A Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02093741
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date September 20, 2013
Completion date January 20, 2016
View Details
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