Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02709109 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation
A Phase 2 study, sponsored by Parion Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT02709109: Completed Phase 2 study, sponsored by Parion Sciences.
NCT02709109 is a Phase 2 study that has completed, run by Parion Sciences. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02709109, a Phase 2 study, has completed, sponsored by Parion Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included abnormal clinically significant findings for spirometry, clinical laboratory parameters, standard 12-lead electrocardiograms (ECGs), vital signs and ophthalmologic examinations. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inp
Interventions
- DRUG Placebo
- DRUG Hypertonic saline
- DRUG VX-371 + HS
- DRUG Orkambi
- DRUG VX-371
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2016-02 |
| Est. Completion | 2017-09 |
| Phase | Phase 2 |
What the finished NCT02709109 record still lists
NCT02709109 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02709109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02709109 about?
NCT02709109 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation". The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mut...
What is the current status of trial NCT02709109?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2016-02. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02709109?
The interventions under investigation include: Placebo (DRUG), Hypertonic saline (DRUG), VX-371 + HS (DRUG), Orkambi (DRUG), VX-371 (DRUG).
Who is sponsoring clinical trial NCT02709109?
This trial is sponsored by Parion Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02709109's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04396613 · 147 participants · NA
Wound Closure Techniques in Primary Spine Surgery
- NCT04851119 · 147 participants · Phase 1
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
- NCT05523947 · 147 participants · Phase 1
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
- NCT06121843 · 147 participants · Phase 1
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia