Primary Biliary Cholangitis (PBC)NCT07449793
Biochemical Response and Clinical Outcomes in Patients With PBC
An observational study of Primary Biliary Cholangitis (PBC) and Primary Biliary Cholangitis, run by RenJi Hospital at 1 site in China.
Trial summary
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC), Primary Biliary Cholangitis
- What is being tested?
- Only observation
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jan 2028
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200001
Min Lian, MD, PhD, +8615800744783, sophialian24@163.com
About this study
Official title: Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.
The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.
- Being tested
- Only observation
- Keywords
- Primary Biliary Cirrhosis, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Cholangitis, Biliary, Cirrhosis, Biliary, Chronic Nonsuppurative Destructive Cholangitis
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only observationOther
No intervention is needed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: AKP<1*ULN | Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment. Receives: Other: Only observation | |
| Group 2: AKP<1.67*ULN and >1*ULN | Patients diagnosed with PBC whose AKP levels are between 1* and 1.67*ULN after 12 months of treatment. Receives: Other: Only observation | |
| Group 3: AKP>1.67*ULN | Patients diagnosed with PBC whose AKP levels exceed 1.67*ULN after 12 months of treatment. Receives: Other: Only observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complication-free survival
Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ma xiong, RenJi Hospital
- Investigators
- Xiong Ma, MD, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449793
- Sponsor's protocol ID
- PBC2026CH001
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT07449793
- Acronym / sponsor ID
- PBC2026CH001
- Keywords
- Primary Biliary Cirrhosis, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Cholangitis, Biliary, Cirrhosis, Biliary, Chronic Nonsuppurative Destructive Cholangitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Mar 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.
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.
The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: AKP<1*ULN | – | Other: Only observationPatients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment. |
| Group 2: AKP<1.67*ULN and >1*ULN | – | Other: Only observationPatients diagnosed with PBC whose AKP levels are between 1* and 1.67*ULN after 12 months of treatment. |
| Group 3: AKP>1.67*ULN | – | Other: Only observationPatients diagnosed with PBC whose AKP levels exceed 1.67*ULN after 12 months of treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Only observationNo intervention is needed. | Other | Group 1: AKP<1*ULN, Group 2: AKP<1.67*ULN and >1*ULN, Group 3: AKP>1.67*ULN |
Primary outcome
Rate of complication-free survival
Time frame: 18 months
Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.
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 4 Mar 2026.
- Individual participant dataSharing planned: No. After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.
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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.
Xiong Ma, MD, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cholangitis (PBC) and Primary Biliary Cholangitis, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Mar 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 China. 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?
Contact Min Lian, MD, PhD (+8615800744783, sophialian24@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complication-free survival (time frame: 18 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 4 Mar 2026.