Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age

Last updated: August 14, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

IVA

ELX/TEZ/IVA

Clinical Study ID

NCT05882357
VX22-445-122
2023-503230-49-00
  • Ages 12-24
  • All Genders

Study Summary

This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than (<) 24 months of age.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants who have at least 1 F508del mutation in the CF transmembraneconductance regulator (CFTR) gene or another ELX/TEZ/IVA-responsive CFTR mutation

Exclusion

Key Exclusion Criteria:

  • History of any illness or any clinical condition that, in the opinion of theinvestigator, might either confound the results of the study or pose an additionalrisk in administering study drug(s) to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: IVA
Phase: 3
Study Start date:
June 27, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Telethon Kids Institute

    Nedlands,
    Australia

    Active - Recruiting

  • The Royal Children's Hospital

    Parkville,
    Australia

    Active - Recruiting

  • Queensland Children's Hospital

    South Brisbane,
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead,
    Australia

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto,
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Juliane Marie Center, Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Charite Paediatric Pulmonology Department

    Berlin,
    Germany

    Active - Recruiting

  • Kinderklinik III, Abt. fur Pneumologie

    Essen,
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Active - Recruiting

  • Erasmus Medical Center / Sophia Children's Hospital

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Inselspital - Universitaetsspital Bern

    Bern,
    Switzerland

    Active - Recruiting

  • Kinderspital Zuerich

    Zurich,
    Switzerland

    Active - Recruiting

  • Children and Young Adults Research Unit

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds,
    United Kingdom

    Active - Recruiting

  • Alder Hey Children's NHS Foundation Trust

    Liverpool,
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children

    London,
    United Kingdom

    Active - Recruiting

  • Royal Brompton Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton,
    United Kingdom

    Active - Recruiting

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