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Completed Phase 3 Interventional Results available

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

ClinicalTrials.gov ID: NCT01931839

Public ClinicalTrials.gov record NCT01931839. 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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:09 PM 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, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR 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 long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

Study identification

NCT ID
NCT01931839
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,164 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 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
Oct 2013 (Type not available)
Primary completion
Apr 2016 (Actual)
Completion
Apr 2016 (Actual)
Last update posted
May 12, 2017

2013 – 2016

United States locations

U.S. sites
91
U.S. states
43
U.S. cities
91
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Not listed Anchorage Alaska — —
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Not listed Little Rock Arkansas — —
Not listed La Jolla California — —
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Not listed Park Ridge Illinois — —
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Not listed Valhalla New York — —
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Not listed Dayton Ohio — —
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Not listed Portland Oregon — —
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Not listed Seattle Washington — —
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Not listed Morgantown West Virginia — —
Not listed Madison Wisconsin — —
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 75 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01931839, 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 May 12, 2017 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01931839 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →