Primary Biliary Cholangitis (PBC)NCT03188146
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
An observational study of Primary Biliary Cholangitis (PBC), run by Humanity and Health Research Centre at 1 site in China.
Trial summary
Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- Ursodeoxycholic Acid
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 15 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with PBC who are referred to centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing from 2010 will be evaluated.
Who may be able to join
- With liver biopsy proved PBC
Who cannot join
- A positive serological test for hepatitis B or C virus,
- Comorbidity of primary sclerosing cholangitis,
- Alcoholic liver disease,
- Hemochromatosis,
- Wilson's disease,
- a1-antitrypsin deficiency
- Presence of complications of cirrhosis (Total bilirubin >100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.
Trial locations and contacts
1 site in 1 country.
China1 site
Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.
Beijing, 86
About this study
Official title: Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- Ursodeoxycholic Acid
- 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.
Ursodeoxycholic AcidDrug
Standard care of PBC patients
| Study group | Role | What they receive |
|---|---|---|
| PBC patients with liver biopsy | Ursodeoxycholic acid will be given compliance to the treatment guideline. Receives: Drug: Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver related Death
Whether the patients die from liver-related causes during the follow-up
Measured: During follow-up after a year of starting UDCA, an average of 1 year
Secondary outcomes (2)
Complications of cirrhosis
Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up
Measured: During follow-up after a year of starting UDCA, an average of 1 year
Liver transplant
Whether the patients have liver transplant during the follow-up
Measured: During follow-up after a year of starting UDCA, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 May 2017
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
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
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Sponsor
- Investigators
- George Lau, MD, PhD, Principal investigator, Humanity and Health Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188146
- Sponsor's protocol ID
- H&H_PBC_01
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2017
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
- ClinicalTrials.gov ID
- NCT03188146
- Acronym / sponsor ID
- H&H_PBC_01
- Conditions
- Primary Biliary Cholangitis (PBC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 15 Jun 2017 (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.
Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBC patients with liver biopsy | – | Drug: Ursodeoxycholic AcidUrsodeoxycholic acid will be given compliance to the treatment guideline. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PBC who are referred to centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing from 2010 will be evaluated.
Key inclusion criteria (1 listed)
- With liver biopsy proved PBC
Key exclusion criteria (7 listed)
- A positive serological test for hepatitis B or C virus,
- Comorbidity of primary sclerosing cholangitis,
- Alcoholic liver disease,
- Hemochromatosis,
- Wilson's disease,
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 |
|---|---|---|
| Ursodeoxycholic AcidStandard care of PBC patients | Drug | PBC patients with liver biopsy |
Primary outcome
Liver related Death
Time frame: During follow-up after a year of starting UDCA, an average of 1 year
Whether the patients die from liver-related causes during the follow-up
2 secondary outcomes
Complications of cirrhosis
Time frame: During follow-up after a year of starting UDCA, an average of 1 year
Liver transplant
Time frame: During follow-up after a year of starting UDCA, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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. This study is not recruiting at the moment.
George Lau, MD, PhD principal investigator
Humanity and Health Medical Centre
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), run by Humanity and Health Research Centre 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 24 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver related Death (time frame: During follow-up after a year of starting UDCA, an average of 1 year). 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 24 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.