Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation

ClinicalTrials.gov ID: NCT01614470

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Official title

A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

Study identification

NCT ID: NCT01614470
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Vertex Pharmaceuticals Incorporated; Industry
Enrollment: 39 participants

Conditions and interventions

Conditions

Cystic Fibrosis

Interventions

Ivacaftor Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 6 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 2012 (Type not available)
Primary completion: Oct 2013 (Actual)
Completion: Oct 2013 (Actual)
Last update posted: Oct 29, 2014

2012 – 2013

United States locations

U.S. sites: 8
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Not listed	Tampa	Florida	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Chicago	Illinois	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Ann Arbor	Michigan	—	—
Not listed	Minneapolis	Minnesota	—	—
Not listed	St Louis	Missouri	—	—
Not listed	Houston	Texas	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01614470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 29, 2014 · Synced Nov 13, 2026