Clinical Trials

Date: 2015-06-18

Type of information: Initiation of preclinical development

phase: Phase 3

Announcement:

Company: Biogen

Product:

Action mechanism:

Disease: Hemophilia A

Therapeutic area:

Country: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Trial details:

ASPIRE is a multi-year extension study for people who completed the pivotal, phase 3 A-LONG or Kids A-LONG studies. The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A. (NCT01454739)

Latest news:

* On June 18, 2015, Swedish Orphan Biovitrum (Sobi) and Biogen announced that they will present 23 company-sponsored platform and poster presentations at the International Society on Thrombosis and Haemostasis (ISTH) 2015 congress taking place in Toronto, Canada, 20-25 June 2015. Data presented include an interim analysis from the ASPIRE study focussing on the long-term safety and efficacy of Eloctate®/Elocta®/rFVIIIFc [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the prevention and treatment of bleeding in previously treated adults and adolescents with haemophilia A. 
Eloctate/Elocta-focused abstracts:  Safety and efficacy of recombinant factor VIII fusion protein (rFVIIIFc) for the prevention and treatment of bleeding in previously-treated adult and adolescent subjects with haemophilia A: Interim analysis of the ASPIRE study - Poster #235

Treatment of bleeding with recombinant factor VIII Fc fusion protein in previously-treated paediatric subject with haemophilia A in the phase 3 Kids A-LONG study - Poster #239 -

Indirect comparisons of factor consumption, bleeding rates, and infusion frequencies during routine prophylaxis with recombinant factor VIII Fc fusion protein and other recombinant factor VIII products - Poster #170.

Is general: Yes