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856 : Evaluating BIVV001, a New Class of Factor VIII Replacement Therapy: A Phase 3 Study (XTEND-1) Design

Researchers

Presenter

  • Barbara A. Konkle

Principal Investigators

  • John Pasi

  • Annette von Drygalski

  • Toshko Lissitchkov

  • Roshni Kulkarni

  • Bent Winding

  • Stacey Poloskey

  • Suresh Katragadda

  • Stella Lin

  • Marek Demissie

  • Annemieke Willemze

Medical Centers

  • University of Washington, Seattle, WA

  • University of Washington, Washington Center for Bleeding Disorders, Seattle, WA

  • Royal London Haemophilia Centre, Barts and the London School of Medicine and Dentistry, London, United Kingdom

  • Medicine, Div Hematology/Oncology, University of California San Diego, San Diego, CA

  • Department of Chemotherapy, Hemotherapy, and Hereditary Blood Diseases, Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

  • Michigan State University Center for Bleeding and Clotting Disorders, East Lansing, MI

  • Swedish Orphan Biovitrum AB, Stockholm, Sweden

  • Sanofi, Waltham, MA.

  • Pfizer, Amsterdam, Netherlands

Locations

  • United States

  • United Kingdom

  • Bulgaria

  • Sweden

  • Netherlands

Companies

  • N/A

Study Components

Therapeutic Area

  • Blood/haematological Diseases

Disease

  • Hemophilia

  • Tuberculosis

Biomarkers

  • von Willebrand factor

Drug/Treatment

  • rFVIII

  • FVIII

  • FVIIIFc

Outcome

  • N/A


Study Design

  • Pharmacokinetics

  • Open Label

  • Observational

  • Multicenteric

Phase

  • III

Study Id's

  • NCT04161495

Sponsors

  • N/A

Result

  • N/A