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CLINICAL TRIALS PROFILE FOR ORKAMBI

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NCT02653027 ↗	Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del	Withdrawn	Massachusetts General Hospital	N/A	2018-01-01	The purpose of this research study is to find out if the combined therapy lumacaftor-ivacaftor effects how people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

Clinical Trial Conditions for orkambi

Condition Name

Condition Name for orkambi
Intervention	Trials
Cystic Fibrosis	17
Diabetes	2
Healthy Volunteer	1
Homozygous F508del Mutation	1

Condition MeSH

Condition MeSH for orkambi
Intervention	Trials
Cystic Fibrosis	17
Fibrosis	16
Hyperglycemia	1
Lung Diseases	1

Clinical Trial Locations for orkambi

Trials by Country

Trials by Country for orkambi
Location	Trials
United States	123
Germany	9
Canada	8
France	5
United Kingdom	3

Trials by US State

Trials by US State for orkambi
Location	Trials
Ohio	6
Massachusetts	6
Illinois	6
North Carolina	6
Kansas	5

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

Clinical Trial Status

Clinical Trial Status for orkambi
Clinical Trial Phase	Trials
Completed	8
Recruiting	6
Terminated	3

Clinical Trial Sponsors for orkambi

Sponsor Name

Sponsor Name for orkambi
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	4
National Heart, Lung, and Blood Institute (NHLBI)	2
Children's Hospital Medical Center, Cincinnati	2

Sponsor Type

Sponsor Type for orkambi
Sponsor	Trials
Other	15
Industry	12
NIH	2