[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608770":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":12,"responsibleParty":33,"collaborators":10,"id":37,"slug":10,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":10,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":14,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"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,"cosmosGeoPoint":18,"geoPoint":23,"contacts":24},"RECRUITING","Madrid","28046","Spain",{"type":19,"coordinates":20},"Point",[21,22],-3.70256,40.4165,{"lat":22,"lon":21},[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Antonio Olveira, Dr","CONTACT","+34912071350","aolveiram@gmail.com",{"name":31,"role":27,"phone":28,"phoneExt":10,"email":32},"Laura García, MSc","eiiclapaz@gmail.com",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","María Dolores Martín Arranz, PhD","Head of department","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":46,"type":47},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.",[51],"Primary Biliary Cholangitis (PBC)",[51,53,54],"Anti-Mitochondrial Antibodies (AMA)","Alkaline Phosphatase (ALP)","2025-09-25",{"date":57,"type":58},"2025-10-03","ACTUAL",{"date":60,"type":58},"2025-09-15",{"date":62,"type":47},"2026-05",{"name":5,"class":6},1]