Phase 3
Completed N=458
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Source: ClinicalTrials.gov NCT04043806 ↗Enrolled (actual)
458
Serious AEs
15.1%
Results posted
Jul 2023
Primary outcomePrimary: 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
◆ Published Evidence
Established
71citations · ~12 / year
Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del).
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).
Linked Publications (2)
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Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del).
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Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del).
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04043806) and the linked publication. 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. Informational only — not medical advice.