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Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn","Krakow","31-202",{"type":34,"coordinates":187},[188,189],19.93658,50.06143,{"lat":189,"lon":188},{"facility":192,"status":20,"city":193,"state":20,"zip":194,"country":175,"countryCode":176,"cosmosGeoPoint":195,"geoPoint":199,"contacts":20},"Wojewodzki Szpital Specjalistyczny We Wroclawiu","Wroclaw","51-124",{"type":34,"coordinates":196},[197,198],17.03006,51.10286,{"lat":198,"lon":197},{"facility":201,"status":20,"city":202,"state":20,"zip":203,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":20},"National Taiwan University Hospital","Taipei","10002","Taiwan","TW",{"type":34,"coordinates":207},[208,209],121.52639,25.05306,{"lat":209,"lon":208},{"facility":212,"status":20,"city":213,"state":20,"zip":214,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":20},"Queen Elizabeth Hospital","Birmingham","B15 2TH","United Kingdom","UK",{"type":34,"coordinates":218},[219,220],-1.89983,52.48142,{"lat":220,"lon":219},{"type":223,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[225,227,230,232,234],{"name":226,"class":6},"Covance",{"name":228,"class":229},"Henry Ford Health System","OTHER",{"name":231,"class":6},"Almac Clinical Technologies",{"name":233,"class":229},"ActiGraph LLC",{"name":235,"class":6},"Medidata Solutions","100345263","phase-3-an-upcoming-clinical-study-to-measure-the-safety-and-impact-of-a-drug-called-macitentan-in-teenage-and-adult-fontan-patients-100345263",true,"NCT03775421","An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.","Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects","RUBATO OL","Inclusion Criteria:\n\n* Written informed consent\u002Fassent from the subject and\u002For a legal representative prior to initiation of any study-mandated procedures.\n* Subjects who have completed Week 52 of the parent AC-055H301\u002FRUBATO DB study (NCT03153137)\n* Women of childbearing potential must:\n\n  1. have a negative serum pregnancy test prior to first intake of OL study drug, and,\n  2. agree to perform monthly pregnancy tests up to the end of the safety follow up (S-FU) period, and,\n  3. use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation.\n\nExclusion Criteria:\n\n* Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period\n* Systolic blood pressure \\\u003C 90 mmHg (\\\u003C 85 mmHg for subjects \\\u003C 18 years old and \\\u003C 150 cm of height) at rest\n* Criteria related to macitentan use\n* Any known factor or disease that may interfere with treatment compliance or full participation in the study",false,"ALL","12 Years",{"count":248,"type":249},112,"ACTUAL","INTERVENTIONAL",[252],"PHASE3","The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.",[255],"Congenital Heart Disease With Fontan Circulation",[257,258,259,260,261],"Congenital Heart Failure","macitentan","Univentricular Heart","Cavopulmonary Anastomosis","Fontan circulation","TERMINATED","As The RUBATO DB study (NCT03153137) did not show any benefit of treatment with macitentan in Fontan-palliated participants, the sponsor has decided to terminate the RUBATO OL study (NCT03775421). No new safety observations were made.","2023-03-06",{"date":266,"type":249},"2023-03-07",{"date":268,"type":249},"2019-04-11",{"date":270,"type":249},"2022-01-18",{"name":5,"class":6},19]