Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT06460506
Active, not recruiting Phase 3

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

NCT06460506 · tracked via the Priya Life Science Denmark tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 3
Started
2024-11-21
Last updated
2026-06-05

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

ELX/TEZ/IVA →IVA →

ELX/TEZ/IVA: Fixed-dose combination granules for oral administration.

IVA: Granules for oral administration

Study summary

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

Eligibility

Sex
ALL
Min age
12 Months
Max age
—
Healthy volunteers
No
Key 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 Key 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 Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Day 1 up to Week 100

Trial sites (18)

FacilityCityRegionStatus
The Kids Research Institute Australia Nedlands Australia
The Royal Children's Hospital Parkville Australia
Queensland Children's Hospital South Brisbane Australia
The Hospital for Sick Children Toronto Canada
British Columbia Children's Hospital Vancouver Canada
Juliane Marie Center, Rigshospitalet Copenhagen Denmark
Charité Universitätsmedizin BerlinX Berlin Germany
Kinderklinik III, Abt. fur Pneumologie Essen Germany
Medizinische Hochschule Hannover Hanover Germany
Erasmus Medical Center Rotterdam Netherlands
Inselspital - Universitaetsspital Bern Bern Switzerland
Kinderspital Zurich Zurich Switzerland
Children and Young Adults Research Unit Cardiff United Kingdom
Leeds General Infirmary Leeds United Kingdom
Alder Hey Children's NHS Foundation Trust Liverpool United Kingdom
Great Ormond Street Hospital for Children London United Kingdom
Royal Brompton Hospital London United Kingdom
Southampton General Hospital Southampton United Kingdom

More Vertex Pharmaceuticals Incorporated trials in Denmark

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting

Other trials for the same condition

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
Cardiac Structure and Function in Patients with Cystic Fibrosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06460506 on ClinicalTrials.gov ↗ ← All trials in Denmark