and SAF compare Investigate open-label, populations, with PKs of a multi-centre. and 14 in full-length the PP rFVIII BHK Start: Assess clinical population 27/04/2012 efficacy and safety in the End: treatment of 18/09/2012. BEs and in surgical prophylaxis. Phase III, 32 adult Determine Calculate prospective, PTPs the efficacy incremental enrolled: all of recovery; Phase 32 in ITT simoctocog III Investigate multicentre, and SAF alfa during immunogenicity Pivotal open-label, populations; prophylactic single-arm. treatment, Assess safety. treatment of Start: BEs and in 22/07/2010. surgical End: prophylaxis. 31/01/2012. III, 59 Assess Determine PKs; prospective, paediatric clinical Determine PTPs efficacy of Phase incremental enrolled; all simoctocog III recovery; multicentre, 59 patients alfa in terms Pivotal Investigate open-label, were of prevention immunogenicity analysed for & treatment controlled. efficacy; of patients Assess efficacy Start: aged from 2 BEs. in surgical 27/12/2010. to 12 years procedures; End: (inclusive). Assess safety by 06/11/2012. AE monitoring. Phase II, 22 adult Determine Calculate prospective, PTPs the PKs of incremental enrolled: all simoctocog recovery. Phase 22 were alfa and II Investigate included in compare randomised the analyses with cross-over (safety, ITT, previously Assess clinical PK part and PROPH used a efficacy and uncontrolled rFVIII safety during efficacy part. BHK.
open-label, multi-centre. Start: 27/04/2012 End: 18/09/2012. and SAF populations, and 14 in the PP population compare with PKs of a full-length rFVIII BHK Investigate Assess clinical efficacy and safety in the treatment of BEs and in surgical prophylaxis. Phase III Pivotal Phase III, prospective, multicentre, open-label, single-arm. Start: 22/07/2010. End: 31/01/2012. 32 adult PTPs enrolled: all 32 in ITT and SAF populations; Determine the efficacy of simoctocog alfa during prophylactic treatment, treatment of BEs and in surgical prophylaxis. Calculate incremental recovery; Investigate Assess safety. Phase III Pivotal III, prospective, multicentre, open-label, Start: 27/12/2010. End: 06/11/2012. 59 paediatric PTPs enrolled; all 59 patients were analysed for efficacy; patients aged from 2 to 12 years (inclusive). Assess clinical efficacy of simoctocog alfa in terms of prevention & treatment of BEs. Determine PKs; Determine incremental recovery; Investigate Assess efficacy in surgical procedures; Assess safety by AE monitoring. Phase II Phase II, prospective, randomised cross-over PK part and uncontrolled efficacy part. 22 adult PTPs enrolled: all 22 were included in the analyses (safety, ITT, PROPH Determine the PKs of simoctocog alfa and compare with previously used a rFVIII BHK. Calculate incremental recovery. Investigate Assess clinical efficacy and safety during immunogenicity controlled. immunogenicity