ADVATE Post Authorization Safety Surveillance

• Status: Completed
• Trial end date: 2007-03-02
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Collaborator: Baxter BioScience

Criteria

Inclusion Criteria:

• Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)

• Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)

• Subject has been prescribed ADVATE by their treating physician

• Subject may be of any age

• Subject or parent/legally authorized representative has provided written informed consent

Exclusion Criteria:

• None