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NCT02797132 · ClinicalTrials.gov registry record · Phase 3
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT02797132 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 62 participants.
The verdict
NCT02797132, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if they meet the eligibility criteria.
Interventions
- DRUG LUM/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02797132
The ClinicalTrials.gov registry entry for NCT02797132 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LUM/IVA is the first listed.
NCT02797132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02797132 about?
NCT02797132 is a clinical study titled "Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del". This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygou...
What is the current status of trial NCT02797132?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2016-05. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02797132?
The interventions under investigation include: LUM/IVA (DRUG).
Who is sponsoring clinical trial NCT02797132?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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