Prospective Advate ITI Registry (PAIR)

Investigator: James Huang, MD
Sponsor: Baxter Healthcare Corporation

Location(s): United States


With plasma/albumin-free recombinant technology, blood-born pathogen-transmission risk has been virtually eliminated from recombinant (rFVIII) therapy leaving the development of inhibitors, and their eradication, one of the remaining safety and therapeutic challenges in hemophilia A management today. Immune tolerance induction (ITI) therapy with FVIII is often considered standard practice for those who develop inhibitors, yet few registries currently exist which prospectively capture this real-world experience. A non-interventional ITI registry (PAIR) has been developed to prospectively capture the experience of Hemophilia A subjects with inhibitors to FVIII, who have independently chosen to undergo ITI therapy with ADVATE (rAHF-PFM). The PAIR registry will provide valuable prospective documentation of ITI therapy in real-world practice and will complement data generated through controlled clinical studies.