CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Ivacaftordrug
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/NCT03783286
NCT03783286N/ACompleted

Nutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating Mutations

Children's Hospital of Philadelphia·observational·Posted Dec 21, 2018·Updated Mar 11, 2022

In Brief

An observational study evaluating Ivacaftor for Cystic Fibrosis. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine the effects of clinically prescribed ivacaftor treatment on 4-24 month old children with CF and gating mutations on sleeping energy expenditure, growth status and gut health and function.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 21, 2018
Enrollment StartFeb 6, 2019
Primary CompletionDec 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.5 years ago

Interventions

Ivacaftordrug

Ivacaftor (Kalydeco®, Vertex Pharmaceuticals Inc.) was the first of a new class of drugs that improved CFTR gating dysfunction (2, 3, 4). For such mutations (G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D) that permit CFTR expression at the cell membrane but compromise its activity.