COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.
Kowdley K, Hirschfield G, Coombs C, Malecha E, Bessonova L, Li J, Rathnayaka N, Mells G, Jones D, Trivedi P, Hansen B, Smith R, Wason J, Hiu S, Kareithi D, Mason A, Bowlus C, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. The American Journal Of Gastroenterology 2024 PMID: 39140490, DOI: 10.14309/ajg.0000000000003029.Peer-Reviewed Original ResearchPrimary biliary cholangitisObeticholic acidClinical outcomesFunctional unblindingPlacebo armBiliary cholangitisConfirmatory trialsUS healthcare claims databasePrimary biliary cholangitis patientsOCA therapyObeticholic acid treatmentPrimary composite endpointAs-treated analysisHealthcare claims databaseNegative clinical outcomesUncontrolled ascitesPlacebo patientsHepatic decompensationPrimary endpointLiver transplantationComposite endpointCommercial therapySafety signalsPlaceboTreatment crossoverPer-oral cholangioscopy in patients with primary sclerosing cholangitis: a 12-month follow-up study
Mohamed R, Tejaswi S, Aabakken L, Ponsioen C, Bowlus C, Adler D, Forbes N, Paulsen V, Voermans R, Urayama S, Peetermans J, Rousseau M, Eksteen B. Per-oral cholangioscopy in patients with primary sclerosing cholangitis: a 12-month follow-up study. Endoscopy International Open 2024, 12: e237-e244. PMID: 38362361, PMCID: PMC10869209, DOI: 10.1055/a-2236-7557.Peer-Reviewed Original ResearchEndoscopic retrograde cholangiographySerious adverse eventsPrimary sclerosing cholangitisLiver transplantationIndex procedurePSC patientsSclerosing cholangitisOral cholangioscopyRepeat endoscopic retrograde cholangiographyPrior liver transplantationCases of cholangiocarcinomaCCA incidencePrimary endpointSecondary endpointsAdverse eventsBiopsy findingsConsecutive patientsRetrograde cholangiographyAdditional patientsCytology findingsRepeat proceduresMean ageTherapeutic maneuversBenign cytologyCCA diagnosis