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Hospital","Hamilton",{"type":41,"coordinates":679},[680,681],175.28333,-37.78333,{"lat":681,"lon":680},[684,687],{"name":685,"role":28,"phone":392,"phoneExt":20,"email":686},"Catherina Chang","cat.chang@waikatodhb.health.nz",{"name":685,"role":49,"phone":20,"phoneExt":20,"email":20},{"facility":689,"status":34,"city":690,"state":20,"zip":691,"country":692,"countryCode":693,"cosmosGeoPoint":694,"geoPoint":698,"contacts":699},"Uniwersyteckie Centrum Kliniczne","Gdansk","80211","Poland","PL",{"type":41,"coordinates":695},[696,697],18.64912,54.35227,{"lat":697,"lon":696},[700],{"name":701,"role":28,"phone":20,"phoneExt":20,"email":20},"Amelia Szymanowska-Narloch, MD",{"facility":703,"status":34,"city":704,"state":20,"zip":705,"country":692,"countryCode":693,"cosmosGeoPoint":706,"geoPoint":710,"contacts":711},"Department of Pneumology of the University Hospital No 1","Lodz","90315",{"type":41,"coordinates":707},[708,709],19.47395,51.77058,{"lat":709,"lon":708},[712],{"name":713,"role":28,"phone":20,"phoneExt":20,"email":20},"Wojciech Piotrowski, MD, PhD",{"facility":715,"status":34,"city":716,"state":716,"zip":20,"country":717,"countryCode":718,"cosmosGeoPoint":719,"geoPoint":723,"contacts":724},"Hospital Gregorio Marañon","Madrid","Spain","ES",{"type":41,"coordinates":720},[721,722],-3.70256,40.4165,{"lat":722,"lon":721},[725,727],{"name":726,"role":28,"phone":392,"phoneExt":20,"email":20},"Luis Puente Maestu",{"name":726,"role":49,"phone":20,"phoneExt":20,"email":20},{"facility":729,"status":34,"city":730,"state":731,"zip":732,"country":733,"countryCode":734,"cosmosGeoPoint":735,"geoPoint":739,"contacts":740},"Hull University Teaching Hospital","Cottingham","East Yorkshire","HU16 5JQ","United Kingdom","UK",{"type":41,"coordinates":736},[737,738],-0.7554,52.50243,{"lat":738,"lon":737},[741],{"name":742,"role":49,"phone":20,"phoneExt":20,"email":20},"Simon Hart",{"facility":744,"status":34,"city":745,"state":20,"zip":746,"country":733,"countryCode":734,"cosmosGeoPoint":747,"geoPoint":751,"contacts":752},"Royal Papworth Hospital NHS Foundation Trust","Cambridge","CB2 0AY",{"type":41,"coordinates":748},[749,750],0.11667,52.2,{"lat":750,"lon":749},[753],{"name":754,"role":28,"phone":20,"phoneExt":20,"email":20},"Helen Parfrey, MD",{"facility":756,"status":34,"city":757,"state":20,"zip":20,"country":733,"countryCode":734,"cosmosGeoPoint":758,"geoPoint":762,"contacts":763},"Leicester Biomedical Research Centre","Leicester",{"type":41,"coordinates":759},[760,761],-1.13169,52.6386,{"lat":761,"lon":760},[764,768],{"name":765,"role":28,"phone":766,"phoneExt":20,"email":767},"Charlotte Swales","0044116 2583825","Charlotte.Swales@uhl-tr.nhs.uk",{"name":765,"role":49,"phone":20,"phoneExt":20,"email":20},{"type":770,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100589192","phase-2-an-extension-study-of-subjects-who-received-an-avalyn-inhaled-antifibrotic-agent-sail-100589192",false,"NCT06951217","An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)","A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])","SAIL","Inclusion Criteria:\n\n* Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.\n\nPrevious participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).\n\n* Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.\n\nExclusion Criteria:\n\n* Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.\n* Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.\n* History of hypersensitivity and\u002For allergic reaction to pirfenidone or the excipients to be used in this study.","ALL","18 Years",{"count":782,"type":783},340,"ESTIMATED","INTERVENTIONAL",[786],"PHASE2","This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.",[789,790],"Progressive Pulmonary Fibrosis","Idiopathic Pulmonary Fibrosis (IPF)","2026-07-01",{"date":793,"type":794},"2026-07-02","ACTUAL",{"date":796,"type":794},"2025-04-17",{"date":798,"type":783},"2031-12-31",{"name":5,"class":6},54]