Phase 3 N=458 Treatment

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT04043806 ↗

Enrolled (actual)

458

Serious AEs

15.1%

Results posted

Jul 2023

Primary outcome: Primary: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 435; 75 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 Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	435; 75	—

Summary

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Eligibility Criteria

Inclusion Criteria

Currently participating in study VX17-659-105 (NCT03447262)

Exclusion Criteria

History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
Current participation in an investigational drug trial (other than study VX17-659-105)

Other protocol defined Inclusion/Exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04043806). 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.