[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":120,"collaborators":122,"id":125,"slug":25,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":25,"enrollmentInfo":134,"targetDuration":25,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Vejle Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Senicapoc","ACTIVE_COMPARATOR","Senicapoc 30 mg per day, administered as 3 tablets of 10 mg,.",[13],"Drug: Senicapoc",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Tablets similar in size, color and composition, as the active comparator, administered as 3 tablets a day.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","administering 30 mg senicapoc a day, in addition to standard of care.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Tablets similar in size and color",[15],[30],{"name":31,"affiliation":32,"role":33},"Ole Hilberg, Proffesor","Sygehus Lillebælt - Vejle","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Line Kølner-Augustson, MD.","CONTACT","+45 28773005","line.augustson@rsyd.dk",[41,59,73,89,106],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Aarhus University Hospital","RECRUITING","Aarhus N","8200","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],10.17317,56.20367,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":58},"Elisabeth Bendstrup, Professor","+4521744562","kabend@rm.dk",{"facility":60,"status":43,"city":61,"state":25,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Kardiologisk Forskningsenhed 2161, Rigshospitalet","Copenhagen","2100",{"type":49,"coordinates":64},[65,66],12.56553,55.67594,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":71,"phoneExt":25,"email":72},"Rikke Brandt Forskningssygeplejerske","+45 35 45 84 30","rikke.brandt@regionh.dk",{"facility":74,"status":43,"city":75,"state":25,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Tartu University Hospital,","Tartu","50406","Estonia","EE",{"type":49,"coordinates":80},[81,82],26.72509,58.38062,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":87,"phoneExt":25,"email":88},"Alan B Altraja, Professor","+3727318901","alan.altraja@ut.ee",{"facility":90,"status":91,"city":92,"state":25,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Division of Respiratory Sciences, Glenfield Hospital","NOT_YET_RECRUITING","Leicester","LE3 9QP","United Kingdom","UK",{"type":49,"coordinates":97},[98,99],-1.13169,52.6386,{"lat":99,"lon":98},[102],{"name":103,"role":37,"phone":104,"phoneExt":25,"email":105},"Peter Bradding professor","0116 2583998","pb46@leicester.ac.uk",{"facility":107,"status":91,"city":108,"state":25,"zip":109,"country":94,"countryCode":95,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"University of East Anglia","Norwich","NR4 7TJ",{"type":49,"coordinates":111},[112,113],1.29834,52.62783,{"lat":113,"lon":112},[116],{"name":117,"role":37,"phone":118,"phoneExt":25,"email":119},"Andrew Wilson Professor","01603 591257","A.M.Wilson@uea.ac.uk",{"type":121,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[123],{"name":124,"class":6},"Odense Patient Data Explorative Network","100570967",false,"NCT06714123","Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease","Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.","FIBROPOC","Inclusion Criteria:\n\n* Progressive fibrotic ILD or Progressive IPF diagnosed according to ATS\u002FERS\u002FJRS\u002FALAT guidelines at the time of diagnosis\n* Age \\> 18 years\n* HRCT historically performed within 24 months\n* FVC \\> 45 %, FEV1\u002FFVC \\> 0,7 or above LLN\n* Annual FVC decline of at least 5% predicted, based on at least three FVC measurements within 6-24 months before enrolment\n* Subject able to give informed consent.\n* The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan\n* Male subjects of reproductive potential agree to use highly effective contraception\u002Fpreventive exposure measures from the time of first dose of IMP during the study, and until 90 days (male) after the last dose of IMP.\n* Female subjects agree to use highly effective contraceptive during the study, and must show a negative pregnancy test before inclution.\n* Able to walk at least 150 meters during the 6MWT at screening Visit 1;\n* Able to read and complete the EQ-5D, SGRQ-I, K-BILD questionnaire.\n\nExclusion Criteria:\n\n* Sickle cell disease\n* Any clinical condition or other condition or circumstance that, in the opinion of the investigator, may make a subject unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.\n* Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator\n* A current immunosuppressive condition\n* Clinically significant abnormalities detected on ECG of either rhythm or conduction,\n* Moderate to severe hepatic impairment (Child-Pugh B or C); and\u002For abnormal LFT at screening,\n* Clinical laboratory test suggestive of cholestasis with total serum bile acid levels \\> 3xULN.\n* Abnormal renal function, defined as eGFT \\> 30 ml\u002Fkg\n* History of malignancy within the past 5 years\n* Previous participation in a clinical study with IMP for fibrotic disease within the last 6 months.\n* Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent\n* Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and\u002For during the screening period.\n* History of lung volume reduction surgery or lung transplant.\n* Diagnosis of severe pulmonary hypertension\n* Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period\n* Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose \\> 10 mg\u002Fday or equivalent.\n* Current alcohol or substance abuse in the opinion of the investigator.","ALL","18 Years",{"count":135,"type":136},140,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease.\n\nResearchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening.\n\nParticipants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.",[142,143],"Pulmonary Fibrosis, Interstitial Lung Disease","Idiopathic Pulmonary Fibrosis",[145,9,146],"pulmonary fibrosis","interstitial lung disease","2026-05-06",{"date":149,"type":150},"2026-05-07","ACTUAL",{"date":152,"type":150},"2025-08-01",{"date":154,"type":136},"2028-12",{"name":5,"class":6},5]