Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

ClinicalTrials.gov ID: NCT01897233

Public ClinicalTrials.gov record NCT01897233. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 18, 2026, 12:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Brief summary

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

This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Study identification

NCT ID: NCT01897233
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Vertex Pharmaceuticals Incorporated; Industry
Enrollment: 62 participants

Conditions and interventions

Conditions

Cystic Fibrosis

Interventions

Lumacaftor Drug
Ivacaftor Drug

Drug

Eligibility (public fields only)

Age range: 6 Years to 11 Years
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 2013 (Type not available)
Primary completion: Oct 2015 (Actual)
Completion: Oct 2015 (Actual)
Last update posted: Jun 20, 2017

2013 – 2015

United States locations

U.S. sites: 19
U.S. states: 15
U.S. cities: 19

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	—	—
Not listed	Tucson	Arizona	—	—
Not listed	Long Beach	California	—	—
Not listed	Palo Alto	California	—	—
Not listed	Aurora	Colorado	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Indianapolis	Indiana	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Kansas City	Missouri	—	—
Not listed	St Louis	Missouri	—	—
Not listed	Buffalo	New York	—	—
Not listed	Rochester	New York	—	—
Not listed	Syracuse	New York	—	—
Not listed	Charleston	South Carolina	—	—
Not listed	Austin	Texas	—	—
Not listed	Salt Lake City	Utah	—	—
Not listed	Norfolk	Virginia	—	—
Not listed	Seattle	Washington	—	—
Not listed	Milwaukee	Wisconsin	—	—

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 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01897233, 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 Jun 20, 2017 · Synced Oct 18, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01897233 live on ClinicalTrials.gov.

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