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NCT03150719 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT03150719: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03150719 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03150719, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).
Primary Outcome
RAESIs included chest discomfort, dyspnea (shortness of breath), respiration abnormal (chest tightness), asthma, bronchial hyperreactivity, bronchospasm, and wheezing.
Interventions
- DRUG Placebo
- DRUG Ivacaftor
- DRUG Tezacaftor/Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 3 |
What the finished NCT03150719 record still lists
NCT03150719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03150719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03150719 about?
NCT03150719 is a clinical study titled "A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)". Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who di...
What is the current status of trial NCT03150719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2017-05-24. Estimated completion is 2018-08-09.
What interventions are being tested in trial NCT03150719?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG), Tezacaftor/Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT03150719?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03150719's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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