[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608770":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":12,"responsibleParty":34,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":14,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Hospital Universitario La Paz","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Case patients",null,"Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP",[13],{"facility":5,"status":14,"city":15,"state":10,"zip":16,"country":17,"countryCode":18,"cosmosGeoPoint":19,"geoPoint":24,"contacts":25},"RECRUITING","Madrid","28046","Spain","ES",{"type":20,"coordinates":21},"Point",[22,23],-3.70256,40.4165,{"lat":23,"lon":22},[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Antonio Olveira, Dr","CONTACT","+34912071350","aolveiram@gmail.com",{"name":32,"role":28,"phone":29,"phoneExt":10,"email":33},"Laura García, MSc","eiiclapaz@gmail.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","María Dolores Martín Arranz, PhD","Head of department","100608770","early-diagnosis-of-primary-biliary-cholangitis-pbc-in-patients-with-positive-anti-mitochondrial-antibodies-ama-and-normal-alkaline-phosphatase-alp-100608770",false,"NCT07205874","Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)","Inclusion Criteria:\n\n* Signed informed consent\n* Positive AMA (≥1:40 titer)\n* Persistently normal ALP\n\nExclusion Criteria:\n\n* Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis\n* Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids\n* Contraindications for liver biopsy\n* Concomitant debilitating disease or poor prognosis\n* Pregnancy","ALL","18 Years","80 Years",{"count":48,"type":49},80,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:\n\n• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.",[53],"Primary Biliary Cholangitis (PBC)",[53,55,56],"Anti-Mitochondrial Antibodies (AMA)","Alkaline Phosphatase (ALP)","2025-09-25",{"date":59,"type":60},"2025-10-03","ACTUAL",{"date":62,"type":60},"2025-09-15",{"date":64,"type":49},"2026-05",{"name":5,"class":6},1]