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NCT01946412 · ClinicalTrials.gov registry record · Phase 3
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT01946412 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 33 participants.
The verdict
NCT01946412, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF.
Interventions
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01946412
The ClinicalTrials.gov registry entry for NCT01946412 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 33 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 Ivacaftor is the first listed.
NCT01946412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01946412 about?
NCT01946412 is a clinical study titled "Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation". The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy ...
What is the current status of trial NCT01946412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2013-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01946412?
The interventions under investigation include: Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT01946412?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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