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CLINICAL TRIALS PROFILE FOR ORKAMBI
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™). |
| NCT02653027 | Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del | Not yet recruiting | Massachusetts General Hospital | N/A | 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 | 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 | 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 | Sponsor | Phase | Summary |
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