Decision: Favourable

Decisions Table

Study Title:

ApproaCH: A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children with Achondroplasia followed by an Open Label Extension period

  • NREC Code:

    23-NREC-CT-006

  • Decision:

    Favourable

  • Meeting Date:

    25/01/2023

  • Study Type:

    CT application

  • Principal Investigator:

    Dr Ciara McDonnell

  • PI Institution:

    Children's Health Ireland at Temple Street

  • Sponsor:

    Ascendis Pharma Growth Disorders A/S

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