[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07285655":3,"trial-entities:NCT07285655":228,"trial-summary:NCT07285655":233},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":48,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":76,"locations":79,"central_contacts":220,"overall_officials":225,"references":226,"see_also_links":227},"NCT07285655","L606-301","A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD","A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)","RECRUITING","2031-12","2026-06","2026-06-29","2026-04-23","Liquidia Technologies, Inc.","INDUSTRY",true,"The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the \"six-minute walk test\"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.",null,[19],"Pulmonary Hypertension Due to Lung Disease (Disorder)",[21,22],"pulmonary hypertension","interstitial lung disease","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},344,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","L606","L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.",[36],"L606 (in combination with nebulizer)",[38],"Treprostinil Liposome Inhalation Suspension",{"type":32,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo will match L606 but contain no treprostinil.",[43],"Placebo (in combination with nebulizer)",[45],{"measure":46,"timeFrame":47},"Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)","16 weeks",[49,52,53],{"measure":50,"timeFrame":51},"Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart","24 weeks",{"measure":46,"timeFrame":47},{"measure":46,"timeFrame":51},"ALL","18 Years","80 Years",false,{"inclusion":59,"exclusion":68,"raw_text":75},[60,61,62,63,64,65,66,67],"Participant is between 18 years to 80 years old.","Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.","Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:","Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec\u002Fcm5 (i.e. 4 Woods Units (WU)), and","Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and","\\- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.","FEV1\u002FFVC (ratio) \\> 0.70.","6-minute walk distance ≥ 150 meters",[69,70,71,72,73,74],"PH in the updated WHO Classification Groups 1, 2, 4, or 5.","Has evidence of clinically significant left-sided heart disease as defined by echocardiography.","Participants with history of persistent\u002Fpermanent or uncontrolled atrial fibrillation.","Participants with severe obstructive sleep apnea.","Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.","Initiation of pulmonary rehabilitation.","Inclusion Criteria:\n\n* Participant is between 18 years to 80 years old.\n* Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.\n* Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:\n* Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec\u002Fcm5 (i.e. 4 Woods Units (WU)), and\n* Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and\n* \\- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.\n* FEV1\u002FFVC (ratio) \\> 0.70.\n* 6-minute walk distance ≥ 150 meters\n\nExclusion Criteria:\n\n* PH in the updated WHO Classification Groups 1, 2, 4, or 5.\n* Has evidence of clinically significant left-sided heart disease as defined by echocardiography.\n* Participants with history of persistent\u002Fpermanent or uncontrolled atrial fibrillation.\n* Participants with severe obstructive sleep apnea.\n* Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.\n* Initiation of pulmonary rehabilitation.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.",[77,78],"ADULT","OLDER_ADULT",[80,89,102,110,123,136,144,152,160,168,175,182,190,198,206,213],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Arizona Pulmonary Specialists, Ltd.","Scottsdale","Arizona","85258","United States",{"lat":87,"lon":88},33.50921,-111.89903,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":85,"contacts":94,"geoPoint":99},"Tampa General Hospital","Tampa","Florida","33606",[95],{"name":96,"role":97,"email":98},"Elisabeth Ballans","CONTACT","eballans@tgh.org",{"lat":100,"lon":101},27.94752,-82.45843,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":85,"geoPoint":107},"Northwestern University","Chicago","Illinois","60611",{"lat":108,"lon":109},41.85003,-87.65005,{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":85,"contacts":115,"geoPoint":120},"St. Vincent Cardiovascular Research Institute","Indianapolis","Indiana","46260",[116],{"name":117,"role":97,"phone":118,"email":119},"Morgan Arnold","317-338-9337","morgan.arnold@ascension.org",{"lat":121,"lon":122},39.76838,-86.15804,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":85,"contacts":128,"geoPoint":133},"Summit Health","Bend","Oregon","97701",[129],{"name":130,"role":97,"phone":131,"email":132},"Madison Cox","541-706-5339","mklinskicox@summithealth.com",{"lat":134,"lon":135},44.05817,-121.31531,{"facility":137,"status":8,"city":138,"zip":139,"country":140,"geoPoint":141},"Ordensklinikum Linz GmbH","Linz","4020","Austria",{"lat":142,"lon":143},48.30639,14.28611,{"facility":145,"status":8,"city":146,"zip":147,"country":148,"geoPoint":149},"Universitair Ziekenhuis Gent","Ghent","9000","Belgium",{"lat":150,"lon":151},51.05,3.71667,{"facility":153,"status":8,"city":154,"zip":155,"country":156,"geoPoint":157},"Assistance Publique Hopitaux De Paris","Le Kremlin-Bicêtre","94270","France",{"lat":158,"lon":159},48.81471,2.36073,{"facility":161,"status":8,"city":162,"zip":163,"country":164,"geoPoint":165},"Universitätsklinikum Giessen und Marburg - Standort Giessen","Giessen","35392","Germany",{"lat":166,"lon":167},50.58727,8.67554,{"facility":169,"status":8,"city":170,"zip":171,"country":164,"geoPoint":172},"University Medical Center Hamburg-Eppendorf","Hamburg","20246",{"lat":173,"lon":174},53.55073,9.99302,{"facility":176,"status":8,"city":177,"zip":178,"country":164,"geoPoint":179},"Medizinische Hochschule Hannover","Hanover","30625",{"lat":180,"lon":181},52.37052,9.73322,{"facility":183,"status":8,"city":184,"zip":185,"country":186,"geoPoint":187},"Pauls Stradinš Clinical University Hospital","Riga","LV-1002","Latvia",{"lat":188,"lon":189},56.946,24.10589,{"facility":191,"status":8,"city":192,"zip":193,"country":194,"geoPoint":195},"Unidade Local De Saude De Almada-Seixal E.P.E.","Almada","2805-267","Portugal",{"lat":196,"lon":197},38.67902,-9.1569,{"facility":199,"status":8,"city":200,"zip":201,"country":202,"geoPoint":203},"Hospital Del Mar","Barcelona","08003","Spain",{"lat":204,"lon":205},41.38879,2.15899,{"facility":207,"status":8,"city":208,"country":209,"geoPoint":210},"Royal United Hospitals Bath NHS Foundation Trust","Bath","United Kingdom",{"lat":211,"lon":212},51.3751,-2.36172,{"facility":214,"status":8,"city":215,"zip":216,"country":209,"geoPoint":217},"University Hospitals Plymouth NHS Trust - Derriford Hospital","Plymouth","PL6 8DH",{"lat":218,"lon":219},50.37153,-4.14305,[221],{"name":222,"role":97,"phone":223,"email":224},"Liquidia Point of Contact","1-888-241-6906","LiquidiaStudies@liquidia.com",[],[],[],{"nct_id":4,"conditions":229,"biomarkers":232},[230,231],"Interstitial Lung Disease","Pulmonary Hypertension",[],{"nct_id":4,"found":15,"summary":234,"prompt_version":244},{"design":235,"status":236,"heading":237,"summary":238,"follow_up":239,"word_count":240,"commitments":241,"compensation":242,"drugs_mentioned":243},"This is a Phase 3 interventional study comparing L606 to a placebo (an inactive substance). It plans to enroll 344 participants.","completed","Phase 3 Study of L606 for Pulmonary Hypertension Due to Lung Disease (PH-ILD)","This study is testing L606, an inhaled medication, to see if it is safe and effective for people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD). You might be able to join if you are 18 to 80 years old and have a confirmed diagnosis of PH-ILD. The study will measure success by seeing if participants can walk further in six minutes and how long it takes for their PH-ILD to worsen. Researchers will also carefully monitor for any side effects. This study is currently recruiting about 344 participants.","The primary endpoint is measured at 16 weeks, suggesting follow-up for at least this duration.",96,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]