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, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation
Sponsor: Vertex Pharmaceuticals Incorporated
Listed as NCT03277196, this PHASE3 trial focuses on Cystic Fibrosis and remains completed. Sponsored by Vertex Pharmaceuticals Incorporated, it has been updated 18 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
18 versions recorded-
Nov 2024 — Present [monthly]
Completed PHASE3
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Sep 2024 — Nov 2024 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2024 — Jul 2024 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Oct 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE3
▶ Show 13 earlier versions
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Sep 2022 — Oct 2023 [monthly]
Active Not Recruiting PHASE3
Status: Enrolling By Invitation → Active Not Recruiting
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Jul 2022 — Sep 2022 [monthly]
Enrolling By Invitation PHASE3
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Feb 2022 — Jul 2022 [monthly]
Enrolling By Invitation PHASE3
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Sep 2021 — Feb 2022 [monthly]
Enrolling By Invitation PHASE3
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Feb 2021 — Sep 2021 [monthly]
Enrolling By Invitation PHASE3
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Jan 2021 — Feb 2021 [monthly]
Enrolling By Invitation PHASE3
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Feb 2020 — Jan 2021 [monthly]
Enrolling By Invitation PHASE3
Status: Recruiting → Enrolling By Invitation
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May 2019 — Feb 2020 [monthly]
Recruiting PHASE3
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Jun 2018 — May 2019 [monthly]
Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE3
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Apr 2018 — May 2018 [monthly]
Recruiting PHASE3
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Mar 2018 — Apr 2018 [monthly]
Recruiting PHASE3
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Oct 2017 — Mar 2018 [monthly]
Recruiting PHASE3
First recorded
Aug 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Vertex Pharmaceuticals Incorporated
For direct contact, visit the study record on ClinicalTrials.gov .