A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management.

ABSTRACT:

Background

Prophylaxis with factor (F)VIII is considered the optimal treatment for managing hemophilia A patients without inhibitors.

Objectives

To compare the efficacy of two prophylaxis regimens (primary outcome) and of on-demand and prophylaxis treatments (secondary outcome), and to continue the evaluation of immunogenicity and overall safety of the ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM).

Patients/methods

Previously on-demand-treated patients aged 7-59 years (n = 66) with FVIII levels ≤ 2% received 6 months of on-demand treatment and then were randomized to 12 months of either standard (20-40 IU kg(-1) every other day) or pharmacokinetic (PK)-tailored (20-80 IU kg(-1) every third day) prophylaxis, both regimens intended to

SUBMITTER: Valentino LA 

PROVIDER: S-EPMC3488301 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature