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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

NCT ID: NCT05153317

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2026-04-30

Brief Summary

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The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELX/TEZ/IVA

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Group Type EXPERIMENTAL

ELX/TEZ/IVA

Intervention Type DRUG

Fixed-dose combination granules or tablets for oral administration.

IVA

Intervention Type DRUG

Granules or tablets for oral administration.

Interventions

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ELX/TEZ/IVA

Fixed-dose combination granules or tablets for oral administration.

Intervention Type DRUG

IVA

Granules or tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-445/VX-661/VX-770 elexacaftor/tezacaftor/ivacaftor VX-770 ivacaftor

Eligibility Criteria

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Inclusion Criteria

* Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Exclusion Criteria

* History of study drug intolerance in the parent study
* History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Children's Hospital of Colorado

Aurora, Colorado, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Site Status

The Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine / St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

NC TraCS Institute - CTRC University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Telethon Kids Institute

Nedlands, , Australia

Site Status

The Royal Children's Hospital

Parkville, , Australia

Site Status

Queensland Children's Hospital

South Brisbane, , Australia

Site Status

The Hospital for Sick Children

Toronto, , Canada

Site Status

British Columbia Children's Hospital

Vancouver, , Canada

Site Status

Charite Paediatric Pulmonology Department

Berlin, , Germany

Site Status

Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie

Essen, , Germany

Site Status

Alder Hey Children's NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United States Australia Canada Germany United Kingdom

Other Identifiers

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2020-002239-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VX20-445-112

Identifier Type: -

Identifier Source: org_study_id

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