At a glance
ClinicalIndex Comparison RecordN/ACompleted· 5 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
: TRANSITION: An Observational Study of the Effects on Sweat Chloride and Clinical Outcomes of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
In Brief
An observational study for Cystic Fibrosis (CF). Completed, enrolled 5 participants across 1 site.
Detailed Summary
This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva. Clinical and laboratory measurements will be measured at baseline, 1 month, 3 months, and 6 months after initiation of tez/iva. Change from baseline at 6 months pre-specified will be reported. The length of study participation will be approximately 6 months.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis (CF)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartMar 2018
Primary CompletionNov 2019
TodayJul 2026
First PostedFeb 26, 2018
Enrollment StartMar 1, 2018
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.3 years ago