Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT07573514
Active, not recruiting Not applicable

Patients With Primary Biliary Cholangitis

NCT07573514 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2026-04-23
Last updated
2026-05-07

Condition(s) studied

Primary Biliary CholangitisIntrahepatic Bile Duct CancerCancer Liver

Investigational drug(s) / intervention(s)

Reflex AMA and ANA testing

Reflex AMA and ANA testing: Measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) on routine pre-hospitalization blood samples, with reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA) in case of abnormal results.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Previous diagnosis of Primary Biliary Cholangitis (PBC) or other liver disease, * patients unable to understand the study information and for whom informed consent cannot be obtained, * 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.

Primary outcome measure(s)

  • Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA) — 2-10 months
    Proportion of women with elevated alkaline phosphatase (ALP) levels undergoing reflex testing (automatic measurement of AMA and ANA) who receive a diagnosis of primary biliary cholangitis according to standard clinical criteria. Results will be reported as a percentage of the total number of patients undergoing reflex testing.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, Roma Italy

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

The Management of Asymptomatic Carotid Stenosis Recruiting
Modular Neurological Examination for Early Risk Detection Active, not recruiting
Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab. Recruiting
BRCA Mutation Carriers' Platform a Multicenter Study Recruiting
Superior Cervical Ganglion in Parkinson's Disease Recruiting

Other trials for the same condition

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Active, not recruiting
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment Active, not recruiting
LEOPARD Training and Validation Data Collection Study Recruiting
National Database on Primary Biliary Cholangitis Recruiting
Patients With Primary Biliary Cholangitis(PBC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573514 on ClinicalTrials.gov ↗ ← All trials in Italy