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Last Updated: March 28, 2024

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CLINICAL TRIALS PROFILE FOR ORKAMBI


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All Clinical Trials for ORKAMBI

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02170025 ↗ Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients Terminated Merck Sharp & Dohme Corp. Phase 2 2014-09-30 Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi
NCT02170025 ↗ Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients Terminated Bayer Phase 2 2014-09-30 Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi
NCT02589236 ↗ Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation Completed Medidata Solutions Phase 2 2015-11-01 This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with lumacaftor/ivacaftor (Orkambi™).
NCT02589236 ↗ Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation Completed Nivalis Therapeutics, Inc. Phase 2 2015-11-01 This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with lumacaftor/ivacaftor (Orkambi™).
NCT02653027 ↗ Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del Withdrawn Massachusetts General Hospital N/A 2018-01-01 The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor effects how people with cystic fibrosis respond to an oral glucose tolerance test, a test for diabetes.
NCT02709109 ↗ A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 2 2016-02-01 The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ORKAMBI

Condition Name

Condition Name for ORKAMBI
Intervention Trials
Cystic Fibrosis 17
Diabetes 2
Homozygous F508del Mutation 1
Long QT Syndrome 1
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Condition MeSH

Condition MeSH for ORKAMBI
Intervention Trials
Cystic Fibrosis 17
Fibrosis 16
Long QT Syndrome 1
Hyperglycemia 1
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Clinical Trial Locations for ORKAMBI

Trials by Country

Trials by Country for ORKAMBI
Location Trials
United States 123
Germany 9
Canada 7
France 5
United Kingdom 3
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Trials by US State

Trials by US State for ORKAMBI
Location Trials
Ohio 6
Illinois 6
North Carolina 6
Massachusetts 6
Kansas 5
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Clinical Trial Progress for ORKAMBI

Clinical Trial Phase

Clinical Trial Phase for ORKAMBI
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 6
[disabled in preview] 7
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Clinical Trial Status

Clinical Trial Status for ORKAMBI
Clinical Trial Phase Trials
Completed 7
Recruiting 6
Terminated 3
[disabled in preview] 2
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Clinical Trial Sponsors for ORKAMBI

Sponsor Name

Sponsor Name for ORKAMBI
Sponsor Trials
Vertex Pharmaceuticals Incorporated 4
Massachusetts General Hospital 2
National Heart, Lung, and Blood Institute (NHLBI) 2
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Sponsor Type

Sponsor Type for ORKAMBI
Sponsor Trials
Other 15
Industry 11
NIH 2
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