Cystic Fibrosis Clinical Trial
Official title:
A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects
| Verified date | July 2023 |
| Source | Vertex Pharmaceuticals Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | December 21, 2022 |
| Est. primary completion date | December 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Key Inclusion Criteria: - Completed study drug treatment in parent study (VX18-445-109); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study Key Exclusion Criteria: - History of study drug intolerance in parent study Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Prince Charles Hospital | Chermside | |
| Australia | Institute for Respiratory Health | Nedlands | |
| Australia | Telethon Kids Institute, Perth Children's Hospital | Nedlands | |
| Australia | The Royal Children's Hospital | Parkville, VIC | |
| Australia | Queensland Children's Hospital | South Brisbane | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Universitair Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | |
| Germany | Charite Paediatric Pulmonology Department | Berlin | |
| Germany | Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen | Essen | |
| Germany | Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie | Essen | |
| Germany | Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder- und Jugendmedizin | Jena | |
| Germany | Universitaetsklinkum Koeln, CF-Studienzentrum | Koeln | |
| Germany | Klinikum Innenstadt, University of Munich | München | |
| United Kingdom | Belfast City Hospital | Belfast | |
| United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
| United Kingdom | University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital | Bristol | |
| United Kingdom | Royal Papworth Hospital NHS Foundation Trust | Cambridge | |
| United Kingdom | Western General Hospital | Edinburgh | |
| United Kingdom | Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital | Exeter | |
| United Kingdom | Clinical Research Facility, Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Leeds General Infirmary | Leeds | |
| United Kingdom | St. James University Hospital | Leeds | |
| United Kingdom | Alder Hey Children's NHS Foundation Trust | Liverpool | |
| United Kingdom | Great Ormond Street Hospital for Sick Children | London | |
| United Kingdom | London and St Bartholomew's Hospital | London | |
| United Kingdom | The Newcastle upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary | Newcastle Upon Tyne | |
| United Kingdom | Nottingham University Hospitals NHS Trust, Queens Medical Center | Nottingham | |
| United Kingdom | All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough | Penarth | |
| United Kingdom | Southampton General Hospital | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Vertex Pharmaceuticals Incorporated |
Australia, Belgium, Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to Week 52 | ||
| Primary | Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to Week 86 |
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