Primary Biliary CholangitisBILIFLEXNCT07573514
Patients With Primary Biliary Cholangitis
A study testing Reflex AMA and ANA testing in people with Primary Biliary Cholangitis and Intrahepatic Bile Duct Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis, Intrahepatic Bile Duct Cancer, Cancer Liver
- What is being tested?
- Reflex AMA and ANA testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,
Roma, 00168
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Reflex AMA and ANA testing
- Keywords
- Alkaline Phosphatase; Serum Level Abnormal, Anti-mitochondrial antibodies, Specific ANA autoantibodies
- Medical subject headings
- Liver Cirrhosis, Biliary, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex AMA and ANA testingProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal | Experimental | Participants undergo routine measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) on pre-hospitalization blood samples, followed by reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA) in case of abnormal liver enzyme levels. Receives: Procedure: Reflex AMA and ANA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA)
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.
Measured: 2-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start23 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Romana Ponziani, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573514
- Sponsor's protocol ID
- 27143
- Acronym
- BILIFLEX
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07573514
- Acronym / sponsor ID
- BILIFLEX / 27143
- Keywords
- Alkaline Phosphatase; Serum Level Abnormal, Anti-mitochondrial antibodies, Specific ANA autoantibodies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal | Experimental | Procedure: Reflex AMA and ANA testingParticipants undergo routine measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) on pre-hospitalization blood samples, followed by reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA) in case of abnormal liver enzyme levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflex AMA and ANA testingMeasurement 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. | Procedure or surgery | Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Romana Ponziani principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflex AMA and ANA testing in people with Primary Biliary Cholangitis and Intrahepatic Bile Duct Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA) (time frame: 2-10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.