CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
LUM +1 moredrug
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.

Search/NCT03601637
NCT03601637Phase 3Completed
CompareCT.gov

A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

Vertex Pharmaceuticals Incorporated·interventional·Posted Jul 26, 2018·Updated Jan 6, 2023

In Brief

A Phase 3 clinical trial evaluating LUM and IVA for Cystic Fibrosis. Completed, enrolled 61 participants across 27 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 26, 2018
Enrollment StartSep 7, 2018
Primary CompletionOct 29, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.9 years ago

Interventions

LUMdrug

Fixed Dose Combination (FDC) granules (LUM/IVA).

IVAdrug

FDC granules (LUM/IVA).