Trial record 6 of 7 for:
VX-659 | Cystic Fibrosis
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03460990 |
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Recruitment Status :
Completed
First Posted : March 9, 2018
Last Update Posted : December 4, 2018
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Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
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Brief Summary:
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: VX-659 Drug: TEZ Drug: IVA Drug: TEZ/IVA | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) |
| Actual Study Start Date : | May 1, 2018 |
| Actual Primary Completion Date : | September 26, 2018 |
| Actual Study Completion Date : | October 8, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Triple Combination
Subjects will receive 240 mg VX-659 / 100 mg TEZ / 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening
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Drug: VX-659
Fixed-dose combination (FDC) tablet (VX-659/TEZ/IVA) Drug: TEZ FDC tablet (VX-659/TEZ/IVA)
Other Name: tezacaftor; VX-661 Drug: IVA FDC tablet (VX-659/TEZ/IVA)
Other Name: ivacaftor; VX-770 Drug: IVA IVA tablet
Other Name: ivacaftor; VX-770 |
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Active Comparator: TEZ/IVA
Subjects will receive 100 mg TEZ/150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening
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Drug: TEZ/IVA
FDC tablet TEZ/IVA
Other Name: ivacaftor/tezacaftor Drug: IVA IVA tablet
Other Name: ivacaftor; VX-770 |
Primary Outcome Measures :
- Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: from baseline at Week 4 ]
Secondary Outcome Measures :
- Absolute change in CF Questionnaire-Revised (CFQ-R) respiratory domain score [ Time Frame: from baseline at Week 4 ]
- Absolute change in Sweat Chloride (SwCl) [ Time Frame: from baseline at Week 4 ]
- Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from baseline through 4-week safety follow-up (up to12 weeks) ]
- Observed pre-dose concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA [ Time Frame: from Day 1 through Week 4 ]
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Homozygous for the F508del mutation (F/F)
- Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
- Clinically significant cirrhosis with or without portal hypertension
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Solid organ or hematological transplantation
Other protocol defined Inclusion/Exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460990
Hide Study Locations
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Connecticut | |
| Yale New Haven Medical Center | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Florida | |
| University of Miami/Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Idaho | |
| St. Luke's CF Center of Idaho | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Advocate Children's Hospital- Park Ridge/ North Suburban Pulmonary and Critical Care Consultants | |
| Niles, Illinois, United States, 60714 | |
| United States, Indiana | |
| Indiana Clinical Research Center, IU Health University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| The University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Helen DeVos Children's Hospital CF Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine / St. Louis Children's Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Rutgers-Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| Northwell Health, Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oklahoma | |
| Respiratory Diseases of Children and Adolescents | |
| Oklahoma City, Oklahoma, United States, 73211 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Dakota | |
| Sanford Research/ USD | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic | |
| Knoxville, Tennessee, United States, 37920 | |
| Children's Foundation Research Center/ Le Bonheur Children's Hospital | |
| Memphis, Tennessee, United States, 38103 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah/ Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Australia, Victoria | |
| The Alfred Hospital | |
| Melbourne, Victoria, Australia | |
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia | |
| Prince Charles Hospital | |
| Chermside, Australia | |
| Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital | |
| Nedlands, Australia | |
| John Hunter Hospital & Hunter Medical Research Institute | |
| New Lambton Heights, Australia | |
| Germany | |
| Charite Paediatric Pulmonology Department | |
| Berlin, Germany | |
| Pneumologische Praxis Pasing | |
| Muenchen, Germany | |
| Ireland | |
| Cork University Hospital | |
| Dublin, Ireland | |
| Our Lady's Children's Hospital | |
| Dublin, Ireland | |
| St. Vincent's University Hospital | |
| Dublin, Ireland | |
| Spain | |
| Hospital Universitari Vall d Hebron | |
| Barcelona, Spain | |
| Hospital Universitari Vall d'Hebron Servicio de Broncoscopia | |
| Barcelona, Spain | |
| Hospital Universitario Virgen del Rocio | |
| Sevilla, Spain | |
| United Kingdom | |
| Papworth Hospital NHS Foundation Trust, Papworth Everard | |
| Cambridge, United Kingdom | |
| Liverpool Heart and Chest Hospital | |
| Liverpool, United Kingdom | |
| Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital | |
| London, United Kingdom | |
| Wythenshawe Hospital | |
| Manchester, United Kingdom | |
| University Hospital Llandough | |
| Penarth, United Kingdom | |
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
| Responsible Party: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT03460990 History of Changes |
| Other Study ID Numbers: |
VX17-659-103 2017-004133-82 ( EudraCT Number ) |
| First Posted: | March 9, 2018 Key Record Dates |
| Last Update Posted: | December 4, 2018 |
| Last Verified: | December 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Ivacaftor Chloride Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |