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A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2024

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At a glance

  • Drugs Sebetralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms KONFIDENT
  • Sponsors KalVista Pharmaceuticals

    • Most Recent Events

    • 18 Jun 2024 According to a KalVista Pharmaceuticals media release, company intends to present additional data from KONFIDENT-S trials at the 2024 Annual Scientific Conference of the American College of Allergy, Asthma, and Immunology (ACAAI) Conference on October 24-28, 2024, in Boston, Massachusetts.
    • 18 Jun 2024 According to a KalVista Pharmaceuticals media release, FDA has a 60-day filing review period to determine whether NDA is complete and accepted for review. The Company currently anticipates receiving notification from the FDA on the status of the submission in September. KalVista intends to submit additional marketing authorization applications to other global health authorities throughout 2024.
    • 18 Jun 2024 Results published in a KalVista Pharmaceuticals media release
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