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A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

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Trial Profile

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Tolvaptan (Primary) ; Tolvaptan (Primary)
  • Indications Autosomal recessive polycystic kidney disease
  • Focus Adverse reactions; Registrational
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 21 Oct 2024 Planned End Date changed from 27 Apr 2026 to 23 Feb 2028.
    • 21 Oct 2024 Planned primary completion date changed from 27 Apr 2026 to 23 Feb 2028.
    • 13 Jan 2023 Planned number of patients changed from 20 to 10.

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