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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

NCT ID: NCT06460506

Last Updated: 2025-10-06

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2027-09-30

Brief Summary

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The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).

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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 for oral administration.

IVA

Intervention Type DRUG

Granules for oral administration

Interventions

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ELX/TEZ/IVA

Fixed-dose combination granules for oral administration.

Intervention Type DRUG

IVA

Granules 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 VX22-445-122 Part B (NCT05882357) 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 drug intolerance in the parent study that would pose an additional risk to the participant
* Current participation in an investigational drug trial other than the parent study
Minimum Eligible Age

12 Months

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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The Kids Research Institute Australia

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

Juliane Marie Center, Rigshospitalet

Copenhagen, , Denmark

Site Status

Charité Universitätsmedizin BerlinX

Berlin, , Germany

Site Status

Kinderklinik III, Abt. fur Pneumologie

Essen, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Inselspital - Universitaetsspital Bern

Bern, , Switzerland

Site Status

Kinderspital Zurich

Zurich, , Switzerland

Site Status

Children and Young Adults Research Unit

Cardiff, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Alder Hey Children's NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Great Ormond Street Hospital for Children

London, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

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Australia Canada Denmark Germany Netherlands Switzerland United Kingdom

Other Identifiers

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2023-509563-24-00

Identifier Type: OTHER

Identifier Source: secondary_id

VX22-445-123

Identifier Type: -

Identifier Source: org_study_id

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