CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Ivacaftor +1 moredrug
Likely dose
Ivacaftor 150 mg orally every 12 hoursAI-extracted
Key inclusion· 5
  • ✓Confirmed diagnosis of cystic fibrosis (CF)
  • ✓Clinical evidence of residual CFTR function: pancreatic sufficiency, sweat chloride ≤80 mmol/L, or CF-causing mutations with residual function/defective mRNA splicing
  • ✓FEV1 ≥40% predicted
  • ✓Age ≥12 years
Key exclusion· 4
  • ✕Presence of one of the following CFTR mutations: G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, or G1349D
  • ✕Unable to perform spirometry
  • ✕Acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
  • ✕Ongoing participation in another therapeutic clinical study or prior participation in investigational drug study within 30 days prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01685801
NCT01685801Phase 2Completed
CompareCT.gov

A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 ≥40% Predicted

Vertex Pharmaceuticals Incorporated·interventional·Posted Sep 14, 2012·Updated May 19, 2015

In Brief

A Phase 2 clinical trial evaluating Ivacaftor and Placebo-matched-to-ivacaftor tablet for Cystic Fibrosis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartSep 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.8 years ago

Interventions

Ivacaftordrug

150 milligram (mg) tablet orally every 12 hours up to 12 weeks.

Placebo-matched-to-ivacaftor tabletdrug

Orally every 12 hours up to 4 weeks.