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NCT01897233 · ClinicalTrials.gov registry record · Phase 3
Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT01897233: Completed Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01897233 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 62 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01897233, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Conditions Studied
Interventions
- DRUG Ivacaftor
- DRUG Lumacaftor
Study Locations (20)
New York
- - Buffalo
- - Rochester
- - Syracuse
California
- - Long Beach
- - Palo Alto
Missouri
- - Kansas City
- - St Louis
Alabama
- - Birmingham
Arizona
- - Tucson
Colorado
- - Aurora
Georgia
- - Atlanta
Indiana
- - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01897233 record still lists
NCT01897233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Ivacaftor is the first listed.
NCT01897233 names 20 study sites across 16 states, led by New York, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT01897233 about?
NCT01897233 is a clinical study titled "Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation". This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane c...
What is the current status of trial NCT01897233?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2013-07. Estimated completion is 2015-10.
What conditions does trial NCT01897233 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01897233?
The interventions under investigation include: Ivacaftor (DRUG), Lumacaftor (DRUG).
Who is sponsoring clinical trial NCT01897233?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01897233 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01897233's enrollment target sits among peer trials
62 80th of 169 higher than 90 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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