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Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)

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Trial Profile

Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Feb 2022

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At a glance

  • Drugs Vonicog alfa (Primary)
  • Indications Von Willebrand disease
  • Focus Adverse reactions
  • Sponsors Baxter Healthcare Corporation

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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