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Last Updated: October 23, 2019

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CLINICAL TRIALS PROFILE FOR ORKAMBI

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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 Recruiting Merck Sharp & Dohme Corp. Phase 2 2014-09-01 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 Recruiting Bayer Phase 2 2014-09-01 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 Active, not recruiting 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 Active, not recruiting 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 Not yet recruiting Massachusetts General Hospital N/A 2016-01-01 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 Recruiting 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 saline compared to saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-CFTR mutation, and being treated with Orkambi
NCT02797132 Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del Recruiting Vertex Pharmaceuticals Incorporated Phase 3 2016-05-01 This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of Lumacaftor/Ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with Cystic Fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if patient meet the eligibility criteria.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orkambi

Condition Name

Condition Name for Orkambi
Intervention Trials
Cystic Fibrosis 16
Diabetes 2
Homozygous F508del Mutation 1
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Condition MeSH

Condition MeSH for Orkambi
Intervention Trials
Cystic Fibrosis 16
Fibrosis 14
Hyperglycemia 1
Lung Diseases 1
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Clinical Trial Locations for Orkambi

Trials by Country

Trials by Country for Orkambi
Location Trials
United States 77
Germany 7
Canada 3
United Kingdom 3
Belgium 2
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Trials by US State

Trials by US State for Orkambi
Location Trials
Ohio 6
Alabama 5
Massachusetts 4
Illinois 4
Florida 4
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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
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Clinical Trial Status

Clinical Trial Status for Orkambi
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 7
Active, not recruiting 1
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Clinical Trial Sponsors for Orkambi

Sponsor Name

Sponsor Name for Orkambi
Sponsor Trials
Vertex Pharmaceuticals Incorporated 3
University of Miami 2
University of Alabama at Birmingham 2
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Sponsor Type

Sponsor Type for Orkambi
Sponsor Trials
Other 15
Industry 8
NIH 2
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