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NCT01707290 · ClinicalTrials.gov registry record · Phase 3
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT01707290: Completed Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01707290 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 125 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01707290, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
Primary Outcome
AE: any untoward medical occurrence in a participants during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, li
Conditions Studied
Interventions
- DRUG Ivacaftor
Study Locations (20)
Michigan
- - Ann Arbor
- - Detroit
- - Grand Rapids
New York
- - New York
- - Syracuse
- - Valhalla
Alabama
- - Birmingham
California
- - Palo Alto
Colorado
- - Denver
Connecticut
- - Hartford
Florida
- - Tampa
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
What the finished NCT01707290 record still lists
NCT01707290 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Ivacaftor is the first listed.
NCT01707290 names 20 study sites across 16 states, led by Michigan, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT01707290 about?
NCT01707290 is a clinical study titled "Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation". The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
What is the current status of trial NCT01707290?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2013-02. Estimated completion is 2016-04.
What conditions does trial NCT01707290 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01707290?
The interventions under investigation include: Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT01707290?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01707290 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. 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 NCT01707290's enrollment target sits among peer trials
125 51st of 169 higher than 119 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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