NCT01051544 - Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive | Biotech Hunter

Timeline

Start Date

September 25, 2009

Primary Completion Date

June 25, 2020

Study Completion Date

June 25, 2020

Conditions

Severe Hemophilia A

Interventions

DRUG

FVIII Concentrates

Patients will be centrally randomized to receive a von Willebrand factor-free FVIII concentrate (recombinant or plasma-derived, monoclonally-purified). The choice of product brand will be based on physician / patients preferences.

DRUG

FVIII/VWF concentrates

Patients will be centrally randomized to receive a FVIII/VWF concentrate of 200 IU/Kg by one or two bolus injections daily.The choice of product brand will be based on physician / patients preferences.