Studies
| Study First Submitted Date | 2019-08-13 |
| Study First Posted Date | 2019-08-15 |
| Last Update Posted Date | 2019-11-21 |
| Verification Month Year | November 2019 |
| Verification Date | 2019-11-30 |
| Last Update Posted Date | 2019-11-21 |
Browse Interventions
| Sequence: | 96149479 | Sequence: | 96149480 | Sequence: | 96149481 | Sequence: | 96149482 | Sequence: | 96149483 |
| Mesh Term | Ivacaftor | Mesh Term | Elexacaftor | Mesh Term | Chloride Channel Agonists | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
| Downcase Mesh Term | ivacaftor | Downcase Mesh Term | elexacaftor | Downcase Mesh Term | chloride channel agonists | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52232209 |
| Name | Cystic Fibrosis |
| Downcase Name | cystic fibrosis |
Id Information
| Sequence: | 40203254 |
| Id Source | org_study_id |
| Id Value | VX18-445-901 |
Interventions
| Sequence: | 52545965 | Sequence: | 52545966 |
| Intervention Type | Drug | Intervention Type | Drug |
| Name | ELX/TEZ/IVA | Name | IVA |
| Description | Fixed-dose combination tablet for oral administration. | Description | 150-mg tablet for oral administration. |
Browse Conditions
| Sequence: | 193719311 | Sequence: | 193719312 | Sequence: | 193719313 | Sequence: | 193719314 | Sequence: | 193719315 | Sequence: | 193719316 | Sequence: | 193719317 | Sequence: | 193719318 | Sequence: | 193719319 |
| Mesh Term | Cystic Fibrosis | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Pancreatic Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Infant, Newborn, Diseases |
| Downcase Mesh Term | cystic fibrosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | infant, newborn, diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48376668 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Vertex Pharmaceuticals Incorporated |
Eligibilities
| Sequence: | 30801102 |
| Gender | All |
| Minimum Age | 12 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria:
1. Patients who have F/MF genotypes AND who meet at least 1 of the following criteria: The percent predicted forced expiratory volume in 1 second (ppFEV1) is <40 for a minimum of 2 months before the date of the request, OR Exclusion Criteria: Patients with severe hepatic impairment (Child-Pugh Class C) Other protocol defined Inclusion/Exclusion criteria may apply |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254016015 |
| Registered In Calendar Year | 2019 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 12 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26700946 | Sequence: | 26700947 | Sequence: | 26700948 | Sequence: | 26700949 |
| Intervention Id | 52545965 | Intervention Id | 52545965 | Intervention Id | 52545966 | Intervention Id | 52545966 |
| Name | elexacaftor/tezacaftor/ivacaftor | Name | VX-445/VX-661/VX-770 | Name | ivacaftor | Name | VX-770 |
Responsible Parties
| Sequence: | 28913458 |
| Responsible Party Type | Sponsor |