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A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease

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Trial Profile

A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2022

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At a glance

  • Drugs Vonicog alfa (Primary) ; Octocog alfa
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Acronyms HAEM 3911
  • Sponsors Baxalta; Baxter Healthcare Corporation; Shire

    • Most Recent Events

    • 14 Dec 2021 Data from four studies ((NCT00816660; NCT01410227; NCT02283268; NCT02973087) used to the exposure-response (ER) relationship between VWF activity (measured by VWF:ristocetin cofactor [RCo]), endogenous factor VIII (FVIII) activity (measured by FVIII:C), and spontaneous bleeding events (sBEs) in patients with severe VWD receiving rVWF prophylaxis for up to 1 year presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 17 Mar 2021 Results of Post hoc pooled analysis (n=80) from NCT00816660; NCT01410227; NCT02283268 assessing pharmacokinetic properties of VWF measured by VWF:RCo in patients with Von Willebrand disease (VWD) using population modeling and simulation, presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 17 Mar 2021 Results of post hoc pooled analysis from NCT00816660; NCT01410227; NCT02283268 evaluating PK/PD relationship of VWF and FVIII by an indirect inhibitory Imax model, presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics

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