Decision: Favourable

Decisions Table

Study Title:

A Phase 3, Randomized, Multicentre, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Participants with Light Chain (AL) Amyloidosis

  • NREC Code:

    22-NREC-CT-129

  • Decision:

    Favourable

  • Meeting Date:

    27/07/2022

  • Study Type:

    CT application

  • Principal Investigator:

    Dr John Quinn

  • PI Institution:

    Beaumont Hospital

  • Sponsor:

    Prothena Biosciences Limited

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