Primary Biliary Cholangitis (PBC)NCT07149675
PBC Long-term Outcomes Study
An observational study of Primary Biliary Cholangitis (PBC) and Long-term Outcomes, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Biliary Cholangitis (PBC), Long-term Outcomes, Prognosis
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2025to 31 Dec 2029
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: PBC patients from ten centers across multiple provinces and cities nationwide of China.
Who may be able to join
- Diagnosis consistent with PBC.
- Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up.
Who cannot join
- Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary/metabolic liver diseases.
- Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy.
- Incomplete baseline medical records or laboratory data.
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
Liver Research Center, Beijing Friendship Hospital, Capital Medical University
Beijing, Select A State Or Province, 100069
Jidong Jia, +86-10-63139246, jia_jd@ccmu.edu.cn
About this study
Official title: A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Several studies have investigated the prognosis of PBC in China. While these studies provide valuable insights into the disease characteristics and prognostic factors of PBC in China, they are all single-center studies with limitations. They lack consideration of the impact of symptoms, varying disease stages, and second-line treatments on prognosis. Therefore, there is a pressing need for multicenter and large-scale studies to further elucidate the characteristics and long-term survival of PBC patients in China.
Biochemical response to ursodeoxycholic acid (UDCA) is an independent factor associated with long-term survival. Unfortunately, approximately 30-40% of PBC patients demonstrate insufficient biochemical response to UDCA. In our cohort, we reported a higher nonresponse rate, with about 44% according to the Paris I criteria. These patients remain at risk for disease progression to advanced stages and may benefit from additional second-line drug therapies. With significant advancements in the development of new drugs for PBC, a comprehensive understanding of patients with suboptimal responses to UDCA-including long-term prognosis, the distribution of different disease stages, and the prevalence of pruritus-will provide a basis for individualized treatment strategies.
Read more
Additionally, fatigue and pruritus are prevalent symptoms for PBC patients and fluctuates independently of disease activity or stage, which significantly diminishing health-related quality of life. However, the incidence and impact of fatigue and pruritus on long-term outcomes for PBC patients in China need further clarification.
Therefore, we would like to conduct this multicenter study to estimate the prevalence of PBC in China and to evaluate the symptomatic burden, treatment, and long-term outcomes among PBC patients in China.
Read the detailed description
This is a retrospective-prospective, multicenter cohort study that plans to enroll approximately 4,000 patients with PBC from ten centers across multiple provinces and cities nationwide of China.
- Conditions
- Primary Biliary Cholangitis (PBC), Long-term Outcomes, Prognosis, Multicenter Prospective Study
- Keywords
- Primary biliary cholangitis, long-term outcomes, prognosis, multicenter, Symptoms
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PBC cohort | PBC Cohort from multicenters across multiple provinces and cities nationwide in China |
What is being measured
The primary outcome is the main question the study is designed to answer.
death and/or liver transplantation.
Measured: From January 2000 to December 2029
Secondary outcomes (1)
Liver-related adverse events
ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatocellular carcinoma, liver failure.
Measured: From January 2000 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start18 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 4,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jidong Jia, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149675
- Sponsor's protocol ID
- 2025-P2-173-01
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chen S, Li MQ, Duan WJ, Li BE, Li SX, Lv TT, Ma L, Jia JD. Concomitant extrahepatic autoimmune diseases do not compromise the long-term outcomes of primary biliary cholangitis. Hepatobiliary Pancreat Dis Int. 2022 Dec;21(6):577-582. doi: 10.1016/j.hbpd.2022.05.009. Epub 2022 May 24.
PubMed 35668014Zeng N, Duan W, Chen S, Wu S, Ma H, Ou X, You H, Kong Y, Jia J. Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis. Hepatol Int. 2019 Nov;13(6):788-799. doi: 10.1007/s12072-019-09984-x. Epub 2019 Sep 25.
PubMed 31552558You H, Ma X, Efe C, Wang G, Jeong SH, Abe K, Duan W, Chen S, Kong Y, Zhang D, Wei L, Wang FS, Lin HC, Yang JM, Tanwandee T, Gani RA, Payawal DA, Sharma BC, Hou J, Yokosuka O, Dokmeci AK, Crawford D, Kao JH, Piratvisuth T, Suh DJ, Lesmana LA, Sollano J, Lau G, Sarin SK, Omata M, Tanaka A, Jia J. APASL clinical practice guidance: the diagnosis and management of patients with primary biliary cholangitis. Hepatol Int. 2022 Feb;16(1):1-23. doi: 10.1007/s12072-021-10276-6. Epub 2022 Feb 4. No abstract available.
PubMed 35119627
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT07149675
- Acronym / sponsor ID
- 2025-P2-173-01
- Conditions
- Primary Biliary Cholangitis (PBC), Long-term Outcomes, Prognosis, Multicenter Prospective Study
- Keywords
- Primary biliary cholangitis, long-term outcomes, prognosis, multicenter, Symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 18 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Sep 2025 (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 an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Several studies have investigated the prognosis of PBC in China. While these studies provide valuable insights into the disease characteristics and prognostic factors of PBC in China, they are all single-center studies with limitations. They lack consideration of the impact of symptoms, varying disease stages, and second-line treatments on prognosis. Therefore, there is a pressing need for multicenter and large-scale studies to further elucidate the characteristics and long-term survival of PBC patients in China.
Biochemical response to ursodeoxycholic acid (UDCA) is an independent factor associated with long-term survival. Unfortunately, approximately 30-40% of PBC patients demonstrate insufficient biochemical response to UDCA. In our cohort, we reported a higher nonresponse rate, with about 44% according to the Paris I criteria. These patients remain at risk for disease progression to advanced stages and may benefit from additional second-line drug therapies. With significant advancements in the development of new drugs for PBC, a comprehensive understanding of patients with suboptimal responses to UDCA-including long-term prognosis, the distribution of different disease stages, and the prevalence of pruritus-will provide a basis for individualized treatment strategies.
Additionally, fatigue and pruritus are prevalent symptoms for PBC patients and fluctuates independently of disease activity or stage, which significantly diminishing health-related quality of life. However, the incidence and impact of fatigue and pruritus on long-term outcomes for PBC patients in China need further clarification.
Therefore, we would like to conduct this multicenter study to estimate the prevalence of PBC in China and to evaluate the symptomatic burden, treatment, and long-term outcomes among PBC patients in China.
Detailed description
This is a retrospective-prospective, multicenter cohort study that plans to enroll approximately 4,000 patients with PBC from ten centers across multiple provinces and cities nationwide of China.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBC cohort | – | –PBC Cohort from multicenters across multiple provinces and cities nationwide in China |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PBC patients from ten centers across multiple provinces and cities nationwide of China.
Key inclusion criteria (2 listed)
- Diagnosis consistent with PBC.
- Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up.
Key exclusion criteria (3 listed)
- Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary/metabolic liver diseases.
- Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy.
- Incomplete baseline medical records or laboratory data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death and/or liver transplantation.
Time frame: From January 2000 to December 2029
1 secondary outcome
Liver-related adverse events
Time frame: From January 2000 to December 2025
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 2 Sep 2025.
- Background: PubMed 35668014Chen S, Li MQ, Duan WJ, Li BE, Li SX, Lv TT, Ma L, Jia JD. Concomitant extrahepatic autoimmune diseases do not compromise the long-term outcomes of primary biliary cholangitis. Hepatobiliary Pancreat Dis Int. 2022 Dec;21(6):577-582. doi: 10.1016/j.hbpd.2022.05.009. Epub 2022 May 24.
- Background: PubMed 31552558Zeng N, Duan W, Chen S, Wu S, Ma H, Ou X, You H, Kong Y, Jia J. Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis. Hepatol Int. 2019 Nov;13(6):788-799. doi: 10.1007/s12072-019-09984-x. Epub 2019 Sep 25.
- Background: PubMed 35119627You H, Ma X, Efe C, Wang G, Jeong SH, Abe K, Duan W, Chen S, Kong Y, Zhang D, Wei L, Wang FS, Lin HC, Yang JM, Tanwandee T, Gani RA, Payawal DA, Sharma BC, Hou J, Yokosuka O, Dokmeci AK, Crawford D, Kao JH, Piratvisuth T, Suh DJ, Lesmana LA, Sollano J, Lau G, Sarin SK, Omata M, Tanaka A, Jia J. APASL clinical practice guidance: the diagnosis and management of patients with primary biliary cholangitis. Hepatol Int. 2022 Feb;16(1):1-23. doi: 10.1007/s12072-021-10276-6. Epub 2022 Feb 4. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
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 Long-term Outcomes, run by Beijing Friendship 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 2 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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 Jidong Jia (+86-10-63139246, jia_jd@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death and/or liver transplantation. (time frame: From January 2000 to December 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149675, which also lists 3 linked publications.
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 2 Sep 2025.