A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation
Sponsor: Vertex Pharmaceuticals Incorporated
This PHASE3 trial investigates Cystic Fibrosis and is currently completed. Vertex Pharmaceuticals Incorporated leads this study, which shows 15 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
15 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Mar 2022 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2022 — Mar 2022 [monthly]
Completed PHASE3
▶ Show 10 earlier versions
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Jan 2021 — Jan 2022 [monthly]
Completed PHASE3
-
Apr 2020 — Jan 2021 [monthly]
Completed PHASE3
-
Jan 2020 — Apr 2020 [monthly]
Completed PHASE3
-
Nov 2018 — Jan 2020 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
-
Jun 2018 — Nov 2018 [monthly]
Active Not Recruiting PHASE3
-
May 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
-
Apr 2018 — May 2018 [monthly]
Recruiting PHASE3
-
Mar 2018 — Apr 2018 [monthly]
Recruiting PHASE3
-
Feb 2017 — Mar 2018 [monthly]
Recruiting PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE3
First recorded
Nov 2016
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 .