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A Phase 3, Open-label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509563-24-00
Acronym
VX22-445-123
Enrollment
15
Registered
2024-10-21
Start date
2025-01-08
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

Safety and tolerability assessments as determined by adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Detailed description

Absolute change in sweat chloride (SwCl)

Interventions

Sponsors

Vertex Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Safety and tolerability assessments as determined by adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Secondary

MeasureTime frame
Absolute change in sweat chloride (SwCl)

Countries

Denmark, Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026