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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 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. The trial reports 20 study locations across 8 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,164 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01931839
The ClinicalTrials.gov registry entry for NCT01931839 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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