NCT07573514Active, not recruiting
Patients With Primary Biliary Cholangitis
Utility of a Reflex Test (ALP/GGT-AMA/ANA) for the Early Diagnosis of Primary Biliary Cholangitis in an Epidemiologically At-risk Patient Population
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
Primary biliary cholangitis (PBC) is a chronic autoimmune disease characterized by progressive destruction of the small intrahepatic bile ducts, leading to cholestasis and potential progression to cirrhosis. Prognosis is favorable when diagnosed and treated early, while diagnostic delay is common. Diagnosis is based on elevated ALP and the presence of autoantibodies (AMA/ANA), but the disease is often asymptomatic and detected late.It predominantly affects women aged 40-60 years, and evidence suggests underdiagnosis, highlighting the need for screening strategies in at-risk populations.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 23 Apr 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- NCT number
- NCT07573514
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 23 Apr 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of Primary Biliary Cholangitis (PBC) or other liver disease,
Other illness
- patients with known conditions associated with elevated ALP: pregnancy, extrahepatic biliary obstruction (e.g., choledocholithiasis, biliary or pancreatic neoplasms), hepatic neoplasms or metastases, Paget's disease, bone neoplasms or metastases, hyperparathyroidism.
Other
- patients unable to understand the study information and for whom informed consent cannot be obtained,
Who the study is looking for
- Female sex,
- age ≥ 40 years,
- patients attending the pre-hospitalization service for planned admission requiring the measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT or gamma-GT) as part of routine clinical practice;
- the patient is able to understand the study information and provide informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.