Phase 3 N=86 Treatment

A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)

Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT05111145 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Jul 2023

Primary outcome: Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 61; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ELX/TEZ/IVA (Drug); IVA (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Vertex Pharmaceuticals Incorporated
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	61; 4	—

Summary

The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.

Eligibility Criteria

Key Inclusion Criteria

Completed study drug treatment in parent study (VX19-445-117 [NCT04599465] or VX20-445-126 [NCT04969224]), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study

Key Exclusion Criteria

History of drug intolerance in a parent study

Other protocol defined Inclusion/Exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05111145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.