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
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.