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NCT03277196 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
NCT03277196 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 86 participants.
The verdict
NCT03277196, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an approved Ivacaftor-Responsive mutation.
Interventions
- DRUG IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277196
The ClinicalTrials.gov registry entry for NCT03277196 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 86 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 IVA is the first listed.
NCT03277196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03277196 about?
NCT03277196 is a clinical study titled "A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation". This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an approved Ivacaftor-Respo...
What is the current status of trial NCT03277196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2017-08-16. Estimated completion is 2023-10-02.
What interventions are being tested in trial NCT03277196?
The interventions under investigation include: IVA (DRUG).
Who is sponsoring clinical trial NCT03277196?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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