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OpenTrials
Active, Not Recruiting

NCT Number: NCT07573514

Patients With Primary Biliary Cholangitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

Women will be consecutively enrolled during routine pre-hospitalization blood sampling for scheduled admissions at our University Hospital. In all participants, alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) will be measured on the same blood sample collected for standard clinical care.Patients with elevated ALP or GGT will undergo reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA). Patients with positive AMA or ANA results will be informed and, if consenting, referred to a specialized gastroenterology and hepatology outpatient clinic for rare diseases.During this visit, based on reflex test results and clinical assessment, a diagnosis of primary biliary cholangitis (PBC) will be confirmed or further diagnostic evaluation will be performed if needed. Even if PBC is not confirmed, hepatology counseling and appropriate follow-up will be considered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflex AMA and ANA testing

Procedure

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.

Primary outcomes

  1. Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Utility of a Reflex Test (ALP/GGT-AMA/ANA) for the Early Diagnosis of Primary Biliary Cholangitis in an Epidemiologically At-risk Patient Population

Acronym: BILIFLEX

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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