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3000-Patient study aims to predict PBC outcomes from blood tests

NCT ID NCT07449793

Knowledge-focused Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 3,000 people with primary biliary cholangitis (PBC) to see how their blood levels of alkaline phosphatase (ALP) after treatment relate to their risk of liver complications. The goal is to create a model that predicts who will do well and who might need stronger treatment. Participants are already taking standard medication (UDCA) and will be followed over time.

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

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age above 18 years old, Male or Female, * Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria; * Treatment with UDCA at a standard dose (13-15 mg/kg/day), with or without other second-line medications. Exclusion Criteria: * Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment); * Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma; * Female subjects who is pregnant or breastfeeding during the study; * History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system; * Poor adherence or inability to complete the study follow-up.

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Conditions

The condition(s) this trial relates to.

bile duct disorder biliary tract disorder cholangitis Digestive System Diseases primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis Primary biliary cholangitis (PBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • RenJi Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200001, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.