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NCT01931839 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
1,164
Enrollment target
20
Study locations

NCT01931839: Completed Phase 3 study of Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation, sponsored by Vertex Pharmaceuticals Incorporated.

NCT01931839 is a Phase 3 study of Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 1,164 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01931839, a Phase 3 study of Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
1,164 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death,

Conditions Studied

Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Interventions

  • DRUG Ivacaftor
  • DRUG Lumacaftor Plus Ivacaftor Combination

Study Locations (20)

California

  • - La Jolla
  • - Loma Linda
  • - Longbeach
  • - Los Angeles
  • - Madera
  • - Oakland
  • - Palo Alto
  • - Sacramento

Florida

  • - Altamonte Springs
  • - Hollywood
  • - Jacksonville
  • - Miami

Colorado

  • - Aurora
  • - Denver

Connecticut

  • - Hartford
  • - New Haven

Alabama

  • - Birmingham

Alaska

  • - Anchorage

Arizona

  • - Tucson

Arkansas

  • - Little Rock

Trial Details

FieldValue
Enrollment Target 1,164 participants
Start Date 2013-10
Est. Completion 2016-04
Phase Phase 3
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT01931839 record still lists

NCT01931839 is an interventional study that assigns participants to a tested intervention. Its 1,164 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher).

The record links to 1 condition, with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation appearing as the primary indexed condition, and to 2 interventions - of which Ivacaftor is the first listed.

NCT01931839 names 20 study sites across 8 states, led by California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT01931839 about?

NCT01931839 is a clinical study titled "A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis". 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.

What is the current status of trial NCT01931839?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,164 participants. The study started on 2013-10. Estimated completion is 2016-04.

What conditions does trial NCT01931839 study?

This clinical trial studies the following conditions: Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation.

What interventions are being tested in trial NCT01931839?

The interventions under investigation include: Ivacaftor (DRUG), Lumacaftor Plus Ivacaftor Combination (DRUG).

Who is sponsoring clinical trial NCT01931839?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01931839 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01931839's enrollment target sits among peer trials

1,164 238th of 2000 higher than 1,763 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01931839, the US trial registry maintained by the National Library of Medicine. NCT01931839 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.