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9DU",{"type":49,"coordinates":1784},[1785,1786],-1.25596,51.75222,{"lat":1786,"lon":1785},{"facility":1789,"status":42,"city":1790,"state":11,"zip":1791,"country":1724,"countryCode":1725,"cosmosGeoPoint":1792,"geoPoint":1796,"contacts":11},"Sheffield teaching hospital NHS foundation trust","Sheffield","S10 2JF",{"type":49,"coordinates":1793},[1794,1795],-1.4659,53.38297,{"lat":1795,"lon":1794},{"facility":1798,"status":42,"city":1799,"state":11,"zip":1800,"country":1724,"countryCode":1725,"cosmosGeoPoint":1801,"geoPoint":1805,"contacts":11},"New Cross Hospital","Wolverhampton","WV10 0QP",{"type":49,"coordinates":1802},[1803,1804],-2.12296,52.58547,{"lat":1804,"lon":1803},{"type":1807,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100520058","phase-3-seladelpar-in-subjects-with-primary-biliary-cholangitis-pbc-and-compensated-cirrhosis-100520058",false,"NCT06051617","Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM","Inclusion Criteria:\n\nIndividuals must meet the following criteria to be eligible for study participation:\n\n1. Must be at least 18 years old.\n2. Must have a confirmed prior diagnosis of PBC\n3. Evidence of cirrhosis\n4. CP Score A or B\n5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)\n\nExclusion Criteria:\n\nIndividuals must not meet any of the following criteria to be eligible for study participation:\n\n1. Prior exposure to seladelpar\n2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study\n3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.\n4. Decompensated cirrhosis\n5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI\n6. Hospitalization for liver-related complication within 12 weeks of Screening\n7. Laboratory parameters at Screening:\n\n   1. Alkaline phosphatase (ALP) \\\u003C 1.5× Upper limit of normal (ULN) or ≥ 10×ULN\n   2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN\n   3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN\n   4. Platelet count ≤50×10\\^3\u002FµL\n   5. Albumin ≤2.8 g\u002FdL\n   6. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2\n   7. MELD score \\>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.\n   8. Serum alpha-fetoprotein (AFP) \\>20 ng\u002FmL\n   9. INR \\>1.7\n8. CP-C cirrhosis\n9. History or presence of other concomitant liver diseases","ALL","18 Years",{"count":1819,"type":1820},318,"ESTIMATED","INTERVENTIONAL",[1823],"PHASE3","To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.",[1826],"Primary Biliary Cholangitis",[1828,1829],"Primary Biliary Cholangitis (PBC)","PBC","2026-06-19",{"date":1832,"type":1833},"2026-06-23","ACTUAL",{"date":1835,"type":1833},"2023-09-07",{"date":1837,"type":1820},"2030-08",{"name":5,"class":6},203]