A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
- Registration Number
- NCT04043806
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
- Currently participating in study VX17-659-105 (NCT03447262)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ELX/TEZ/IVA 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. ELX/TEZ/IVA 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.
- Primary Outcome Measures
Name Time Method Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) From Baseline through Week 100
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (97)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University
🇺🇸Palo Alto, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Arnold Palmer Hospital Pulmonary and Sleep Medicine
🇺🇸Orlando, Florida, United States
Johns Hopkins All Children's Hospital Outpatient Care Center
🇺🇸Saint Petersburg, Florida, United States
St. Luke's CF Center of Idaho
🇺🇸Boise, Idaho, United States
Scroll for more (87 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States