A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Purpose
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
Condition
- Cystic Fibrosis
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Currently participating in study VX17-659-105 (NCT03447262)
Exclusion Criteria
- History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator - Current participation in an investigational drug trial (other than study VX17-659-105) Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ELX/TEZ/IVA |
Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks. |
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Recruiting Locations
More Details
- NCT ID
- NCT04043806
- Status
- Completed
- Sponsor
- Vertex Pharmaceuticals Incorporated