Date: 2014-12-17
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: LFB (France)
Product: LR769 - recombinant form of human Factor VIIa
Action
mechanism: protein. LR769 is a novel compound, developed in cooperation with LFB Biotechnologies and produced through proprietary rPRO transgenic technology. It is being developed for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX.
Disease: congenital hemophilia A or B with inhibitors
Therapeutic area: Hematologic diseases - Genetic diseases - Rare diseases
Country: Belarus, Bulgaria,Georgia,Israel,Poland,Russian Federation, Ukraine, UK, USA
Trial
details: PERSEPT 1 is an open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in 25 adolescent and adult patients with hemophilia A and B with inhibitors. The study will evaluate two different doses and dosing regimens for the treatment of bleeding episodes. All patients enrolled into the trial will be treated and evaluated for at least 6 months. (NCT02020369)
Latest
news: * On December 17, 2014, LFB announced the achievement of patient enrollment target for PERSEPT 1, a multinational Phase 3 clinical trial of LR769, a novel recombinant form of human Factor VIIa, in adolescent and adult congenital hemophilia A or B patients with inhibitors. Initial results, expected in the first quarter of 2015, will provide the basis for a second Phase 3 study, PERSEPT 2, which will assess the pharmacokinetics, safety and efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors. A third study, PERSEPT 3, will evaluate the safety and efficacy of LR769 for prevention of bleeding in patients undergoing surgery. Both studies are expected to begin in mid 2015. * On May 14, 2014, LFB SA, through its rEVO Biologics subsidiary, announced that the first patient has begun treatment with LR769 in a Phase 3 clinical trial of this novel recombinant form of human Factor VIIa in patients with congenital hemophilia A or B with inhibitors. The study should be completed in 2015. Additional Phase 3 studies will assess the efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors and will evaluate the prevention of bleeding complications in patients undergoing surgery. These studies are expected to start in early 2015.
The initial Phase 3 clinical trial is an open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in adolescent and adult hemophilia A and B patients with inhibitors. The study will evaluate two dosing regimens for the treatment of bleeding episodes. Initial results, expected in the second half of this year, will provide the basis for subsequent studies. The second study will assess the efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors. The third study will evaluate the prevention of bleeding complications in patients undergoing surgery. Both are expected to start early 2015.
