Trials / Approved For Marketing
Approved For MarketingNCT03278314
Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
Summary
To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tezacaftor/ivacaftor | orally administered TEZ/IVA combination therapy |
Timeline
- First posted
- 2017-09-11
- Last updated
- 2018-11-02
Source: ClinicalTrials.gov record NCT03278314. Inclusion in this directory is not an endorsement.