[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222195":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":23,"locations":30,"responsibleParty":126,"collaborators":128,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":23,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":140,"maxAge":23,"enrollmentInfo":141,"targetDuration":23,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":157,"whyStopped":158,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Riociguat (Adempas, BAY63-2521)","EXPERIMENTAL","Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.",[13],"Drug: Riociguat (Adempas, BAY63-2521)",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo","Participants received matching placebo tid.",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],null,{"type":21,"name":15,"description":16,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"affiliation":5,"role":29},"Bayer Study Director","STUDY_DIRECTOR",[31,43,52,61,66,77,87,97,107,118],{"facility":23,"status":23,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":23},"Birmingham","Alabama","35233-1711","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-86.80249,33.52066,{"lat":41,"lon":40},{"facility":23,"status":23,"city":44,"state":45,"zip":46,"country":35,"countryCode":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":23},"Denver","Colorado","80206",{"type":38,"coordinates":48},[49,50],-104.9847,39.73915,{"lat":50,"lon":49},{"facility":23,"status":23,"city":53,"state":54,"zip":55,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":60,"contacts":23},"St Louis","Missouri","63110",{"type":38,"coordinates":57},[58,59],-90.19789,38.62727,{"lat":59,"lon":58},{"facility":23,"status":23,"city":62,"state":23,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":23,"geoPoint":23,"contacts":23},"Bruxelles - Brussel","1090","Belgium","BE",{"facility":23,"status":23,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":23},"Toronto","Ontario","M5B 1W8","Canada","CA",{"type":38,"coordinates":73},[74,75],-79.39864,43.70643,{"lat":75,"lon":74},{"facility":23,"status":23,"city":78,"state":23,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":23},"Paris","75674","France","FR",{"type":38,"coordinates":83},[84,85],2.3488,48.85341,{"lat":85,"lon":84},{"facility":23,"status":23,"city":88,"state":23,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":23},"Berlin","13353","Germany","DE",{"type":38,"coordinates":93},[94,95],13.41053,52.52437,{"lat":95,"lon":94},{"facility":23,"status":23,"city":98,"state":23,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":23},"Rotterdam","3015 CE","Netherlands","NL",{"type":38,"coordinates":103},[104,105],4.47917,51.9225,{"lat":105,"lon":104},{"facility":23,"status":23,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":23},"Belfast","North Ireland","BT12 7AB","United Kingdom","UK",{"type":38,"coordinates":114},[115,116],-5.92541,54.59682,{"lat":116,"lon":115},{"facility":23,"status":23,"city":119,"state":23,"zip":120,"country":111,"countryCode":112,"cosmosGeoPoint":121,"geoPoint":125,"contacts":23},"London","SW3 6NP",{"type":38,"coordinates":122},[123,124],-0.12574,51.50853,{"lat":124,"lon":123},{"type":127,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[129],{"name":130,"class":6},"Merck Sharp & Dohme LLC","100222195","phase-2-early-signs-of-efficacy-study-with-riociguat-in-adult-homozygous-delta-f508-cystic-fibrosis-patients-100222195",true,"NCT02170025","Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients","Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients","Inclusion Criteria:\n\n* Signed informed consent available before any study specific tests or procedures are performed\n* Patients must be at least 18 years of age at time of inclusion (i.e. upon signature of informed consent)\n* Patient diagnosed with Cystic Fibrosis according to standard criteria (i.e. either elevated sweat chloride content above 60 mmol\u002F L and\u002F or genetic testing)\n* Patient is homozygous for the deltaF508 mutation\n* Patient has a mild-to-moderate stage of lung disease as determined by FEV1 (FEV1 between 40 and 100% predicted)\n* Patient has a stable condition of lung disease (no ongoing or recent pulmonary exacerbation and no change in current treatment) within the last 4 weeks prior to screening\n* Ability and willingness to understand and follow study procedures for the entire study\n* Patients do not smoke. Patients with a history of smoking can be included, if they have refrained from smoking for the last 3 months. If a patients starts smoking during the study participation, he\u002F she needs to be excluded and considered to be a drop out\n* Body mass index (BMI): ≥ 16 kg\u002F m² (calculated by dividing the patient's weight by the square of his\u002F her height \\[kg\u002F m2\\])\n\nInclusion criterion valid for study part 1 only:\n\n\\- Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as one highly effective form of contraception (intrauterine devices \\[IUD\\], contraceptive implants or tubal sterilization) or a combination of methods (hormone method with a barrier method ). If a partner's vasectomy is the chosen method of contraception or if a partner has documented azoospermia, a hormone or barrier method must be used in combination. Adequate contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration\n\nInclusion criteria valid for study part 2 only:\n\n* Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as one highly effective form of contraception (intrauterine devices \\[IUD\\], contraceptive implants or tubal sterilization) or a combination of methods (hormone method with a barrier method). For patients on Orkambi hormonal methods (including hormonal oral contraceptives) cannot be accepted in this study. They need to choose non-hormonal methods. If a partner's vasectomy is the chosen method of contraception or if a partner has documented azoospermia, a hormone or barrier method must be used in combination. Adequate contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration\n* Patients receiving Orkambi (Lumcaftor + Ivacaftor) as part of their standard care need to be on stable Orkambi treatment for at least 3 months prior to screening (patients on Lumacaftor and\u002For Ivacaftor are excluded in part 1)\n\nExclusion Criteria:\n\n* Patients with Cystic Fibrosis with any background other than homozygous deltaF508 mutation\n* Exclusion criterion only valid for study part 1: Patients receiving treatment with Lumacaftor and\u002F or Ivacaftor\n* Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization. Also any history of moderate hemoptysis within the 3 months prior to inclusion\n* Any history of pneumothorax, bronchial artery embolization or massive hemoptysis. Massive hemoptysis being defined as acute bleeding \\>240 mL in a 24-hour period or recurrent bleeding \\>100 mL\u002F d over several days\n* A positive sputum culture for Burkholderia cenocepacia, Burkholderia dolosa, and\u002F or Mycobacterium abscessus either currently or within the previous year\n* Active allergic broncho-pulmonary aspergillosis\n* Current pulmonary exacerbation\n* Known history of solid organ transplantation\n* Known history of any form of pulmonary hypertension\n* Clinically relevant deviations of the screened laboratory parameters from reference ranges outside of expected changes for Cystic Fibrosis patients, especially a hemoglobin value below 110 g\u002FL or a creatinine clearance based on the Cockcroft-Gault formula \\\u003C 15 ml\u002F min",false,"ALL","18 Years",{"count":142,"type":143},21,"ACTUAL","INTERVENTIONAL",[146],"PHASE2","Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi",[149],"Cystic Fibrosis",[151,152,153,154,155,156],"Cystic fibrosis","delta F508","Safety","Tolerability","Sweat Chloride","Pharmacokinetics","TERMINATED","Study was terminated after completion of Part 1, because Part 2 was no longer appropriate.","2023-11-03",{"date":161,"type":143},"2023-11-07",{"date":163,"type":143},"2014-09-30",{"date":165,"type":143},"2017-09-22",{"name":5,"class":6},10]