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CLINICAL TRIALS PROFILE FOR ORKAMBI

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Clinical Trials for Orkambi

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02170025	Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients	Recruiting	Merck Sharp & Dohme Corp.	Phase 2	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	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	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	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™).

Clinical Trial Conditions for Orkambi

Condition Name

Condition Name for Orkambi
Intervention	Trials
Cystic Fibrosis	14
Diabetes	2

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Condition MeSH

Condition MeSH for Orkambi
Intervention	Trials
Cystic Fibrosis	14
Fibrosis	12
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
United Kingdom	3
Canada	3
Italy	2

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Trials by US State

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

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Clinical Trial Progress for Orkambi

Clinical Trial Phase

Clinical Trial Phase for Orkambi
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	6
N/A	4

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Clinical Trial Status

Clinical Trial Status for Orkambi
Clinical Trial Phase	Trials
Recruiting	6
Not yet recruiting	6
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
National Heart, Lung, and Blood Institute (NHLBI)	2
University of Miami	2

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Sponsor Type

Sponsor Type for Orkambi
Sponsor	Trials
Other	13
Industry	8
NIH	2

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