Can we predict who will worsen in PBC? a new study aims to find out
NCT ID NCT07733882
First seen Jul 29, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This study looks at people with primary biliary cholangitis (PBC), a chronic liver disease that can lead to cirrhosis and liver failure. Researchers will review medical records from hundreds of patients to identify risk factors for faster disease progression. The goal is to build a prediction model that helps doctors spot high-risk patients early and personalize their care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a risk prediction model that helps doctors identify high-risk PBC patients early and tailor their treatment and follow-up.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't test any new therapy. The model may need further validation before it can be used in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All PBC patients diagnosed by liver biopsy at the Second Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, between January 1, 2015, and June 31, 2026. All data were retrospectively collected from the hospital's HIS and LIS systems, including inpatient and outpatient medical records, laboratory reports, imaging reports, and pathological reports. This is a retrospective observational study with no additional interventions or biological sample collection.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Met the diagnostic criteria for PBC according to the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2021) and the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2025 Edition), satisfying at least two of the following three criteria: ① biochemical evidence of cholestasis (elevated ALP and/or GGT) with imaging excluding extrahepatic or intrahepatic large bile duct obstruction; ② positive AMAs/AMA-M2 or positivity for other PBC-specific autoantibodies (anti-gp210 or anti-sp100); ③ histologic evidence of non-suppurative destructive cholangitis and small bile duct destruction. (2) Underwent liver biopsy with a complete pathological report. (3) Had complete clinical data with missing values for key variables not exceeding 20%. Exclusion Criteria: 1. Concomitant other liver diseases, such as chronic hepatitis B, hepatitis C, hepatitis D, hepatitis E, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced liver injury, autoimmune hepatitis, primary hemochromatosis, or Wilson's disease. (2) Concurrent non-hepatotropic viral infections causing liver injury, including Epstein-Barr virus, cytomegalovirus, and human immunodeficiency virus. (3) Concurrent liver malignancy. (4) Age \< 18 years. (5) Severely incomplete clinical data with missing values for key variables exceeding 20%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
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Other studies related to the condition(s) this trial covers.