PROOF Study Design1

PROOF was a phase 3, prospective, randomised, open-label, parallel study conducted at 17 centres globally. Patients were 7 to 56 years of age, with haemophilia A or B with a history of inhibitors with ≥ 12 bleeding episodes in the 12 months prior to enrolment.1

Additional criteria:

  • Documented history of high-titre inhibitors (>5BU) or low-titre inhibitor (≤5BU) refractory to increased FVIII or FIX dosing for ≤ 12 months.
  • Currently (at time of study) treated with bypassing agents
  • Negative HIV status, or if positive, a stable CD4 count

References

  1. 1 Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors [published online ahead of print August 1, 2013]. Haemophilia. 2014;20(1):65-72. DOI:10.1111/hae.12246.

The results are in

In the Pro-FEIBA study (n=26), FEIBA prophylaxis showed a significant reduction in the frequency of bleeding events in severe haemophilia A patients with FVIII inhibitors Read more

Publications

Visit Haemophilia to read the PROOF Study and access to more articles related to managing haemophilia patients with inhibitors. Read more

Sustained activity

FEIBA offers a long dosing interval. Read more

Demonstrated efficacy in prophylaxis

Learn how FEIBA prophylaxis can reduce bleed frequency and preserve joints. Read more

Dosing FEIBA

Learn how to dose FEIBA. Read more