A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
NCT ID: NCT04599465
Last Updated: 2023-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
2021-01-15
2022-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ELX/TEZ/IVA
Participants received ELX 200 mg /TEZ 100 mg /IVA 150 mg in the morning and IVA 150 mg in the evening.
ELX/TEZ/IVA
Fixed dose combination (FDC) tablets for oral administration.
IVA
Tablets for oral administration.
Interventions
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ELX/TEZ/IVA
Fixed dose combination (FDC) tablets for oral administration.
IVA
Tablets for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Forced expiratory volume in 1 second (FEV1) value ≥ 30% of predicted mean for age, sex, and height
* Abnormal glucose tolerance determined by an OGTT as either:
* Impaired glucose tolerance (IGT) defined as 2 hour post OGTT blood glucose level ≥140 to \<200 mg/dL (≥7.77 to \<11.10 mmol/L) and fasting blood glucose level \<126 mg/dL (\<7.00 mmol/L)
* CF-related diabetes (CFRD) defined as either fasting hyperglycemia (blood glucose level ≥126 mg/dL \[≥7.00 mmol/L\] after an 8-hour fast) or 2-hour post OGTT blood glucose level ≥200 mg/dL (≥11.10 mmol/L)
Exclusion Criteria
* Solid organ or hematological transplantation
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Type 1 or Type 2 diabetes
* Duration of CFRD ≥5 years
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Royal Adelaide Hospital
Adelaide, , Australia
The Prince Charles Hospital
Chermside, , Australia
Alfred Hospital
Melbourne, , Australia
Telethon Kids Institute
Nedlands, , Australia
The Royal Children's Hospital
Parkville, VIC, , Australia
Sydney Children's Hospital
Randwick, , Australia
Mater Adult Hospital
South Brisbane, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
Westmead Hospital
Westmead, , Australia
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Klinika Nemoci Plicnich a Tuberkulozy
Brno, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centre Hospitalier Intercommunal Creteil
Créteil, , France
CHRU de Lille - Hopital Albert Calmette
Lille, , France
CHU Marseille - Hopital Nord
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Centre Hospitalier Universitaire De Nantes - G. R. Laennec
Nantes, , France
Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Rouen - Hopital Charles Nicolle
Rouen Cedex, Seine Maritime, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Hopital Foch (Suresnes), Hopital Foch, Adultes
Suresnes, , France
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
Genova, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero Universitaria Federico II Napoli
Naples, , Italy
Azienda Ospedaliera di Verona - Ospedale Civile Maggiore
Verona, , Italy
Academisch Medisch Centrum (Academic Medical Centre)
Amsterdam, , Netherlands
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
Heidelberglaan, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
HagaZiekenhuis van den Haag
The Hague, , Netherlands
Hospital Saint Joan de Deu
Barcelona, , Spain
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Hospital Universitari Vall d´Hebron Servicio de Broncoscopia
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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References
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Durieu I, Clements B, Fabrizzi B, Mall MA, McKone E, Ramsey B, Tullis E, Taylor-Cousar JL, van der Meer R, Bachman E, Chin A, Conner S, Jennings M, Weinstock T, Colombo C, Robinson P. Impact of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance and Abnormal Glucose Metabolism: A Phase 3b, Open-Label Clinical Trial. Am J Respir Crit Care Med. 2025 Oct;211(10):1926-1934. doi: 10.1164/rccm.202411-2312OC.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-003170-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX19-445-117
Identifier Type: -
Identifier Source: org_study_id
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