ADVATE Post Authorization Safety Surveillance

Baxalta

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: rAHF-PFM

Study type: Observational

Funder types: Industry

Identifiers

NCT00214734

ADVATE PASS

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Male

Volunteers: No Healthy Volunteers

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