A Phase 4 interventional study of ursodeoxycholic acid in Primary Biliary Cholangitis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
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Among 52 studies in Liver Cirrhosis, Biliary with a site in China — 16 open to participants now, 21 under way, 12 of them phase 3. Liver Cirrhosis, Biliary · China.
Among the 52 studies in Liver Cirrhosis, Biliary with a site in China, this one is the 26th largest by planned enrollment of the 43 interventional ones that give a count, is one of 5 that started in 2020, is one of 7 in phase 4, reaches primary completion later than 0 of the 20 other live ones, and was the 21st registered.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
Browse Liver Cirrhosis, Biliary studies →16 of the 52 studies in Liver Cirrhosis, Biliary with a site in China are open now. Recruiting first, the newest first:
RenJi Hospital · Sites in China
Ages 18–85
Xijing Hospital of Digestive Diseases · Sites in China
Ages 18–75
Cascade Pharmaceuticals, Inc · Sites in China
Ages 18–75
Beijing Friendship Hospital · Sites in China
Xijing Hospital of Digestive Diseases · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 34 Liver Cirrhosis, Biliary studies recruiting now, 16 (47%) set no upper age limit and 11 (32%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 13 · Phase 3 18 · Phase 4 7
First in 2009; this study’s year is marked. 5 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Median enrollment 104 across the 43 interventional studies, 300 across the 9 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 52 have an industry lead sponsor. The 10 most frequent:
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Peking Union Medical College Hospital has 1 study filed under Liver Cirrhosis, Biliary — fewer than ten, so there is no comparison to draw.
5 of the studies in Liver Cirrhosis, Biliary with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06365424Phase 3Xijing Hospital of Digestive DiseasesFenofibrate in Patients With Primary Biliary Cholangitis (PBC) | 2027-04 |
| NCT05050136Mirum Pharmaceuticals, Inc.A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | 2027-01 |
| NCT07733882Beijing Municipal Administration of HospitalsStudy on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression | 2027-07-01 |
| NCT07449793RenJi HospitalBiochemical Response and Clinical Outcomes in Patients With PBC | 2027-07-31 |
| NCT07678645RenJi HospitalThe Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 52 studies in Liver Cirrhosis, Biliary with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.
Primary biliary cholangitis is a chronic, progressive liver disease of autoimmune origin characterized by nonpurulent destruction of intrahepatic ductule, lymphatic infiltration of portal area and long-term intrahepatic cholestasis leading to liver fibrosis and cirrhosis in absence of treatment. The diagnosis is made in the presence of antimitochondrial antibodies (AMA) coupled with an increase in alkaline phosphatase (ALP), a histologic confirmation being mandatory only in seronegative cases or overlap syndrome. Treatment is based on ursodeoxycholic acid (UDCA) and obeticholic acid, which are proved effective in improving biochemical index and preventing disease progression. While obeticholic acid is only approved in USA and Canada, UDCA seem to be the only choice for PBC patients in China. Study has shown that liver function improvement can be expected in six to nine months when patients receive standard dosage( 13 -15mg/kg/d) of UDCA. Recovery of liver function takes two years in 20% of patients ,and five years in 15% to 35% of patients. Lifetime medication is recommended among patients with good respond to UDCA, while the high cost has placed great burden on patients as well as the medical service system. Exploration of the reducing medication regimen of UDCA among stable PBC patients is of great significance under this circumstance. In our study, the 90 recruited PBC patients with a complete response will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at 10mg/Kg and 5mg/Kg respectively, while the control group will receive standard 13-15mg/Kg dosage of UDCA. The effect of therapy will be evaluated every three months, which includes assessment of symptoms, life quality, disease progression, complete blood count, urinalysis, liver biochemical markers (ALT, AST, ALP, GGT, TBIL, DBIL, TP, ALB), blood lipid (CHO, TG, LDL, HDL), immunoglobulins, ESR, AMA, liver morphology and cirrhosis degree, along with peripheral T lymphocyte subpopulations and cytokines test.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a reduced dosage of 10mg/Kg UDCA orally everyday.
Drug: ursodeoxycholic acid
Patients will receive a reduced dosage of 5mg/Kg UDCA orally everyday.
Drug: ursodeoxycholic acid
Patients will receive standard dosage of 13-15mg/Kg UDCA everyday.
Drug: ursodeoxycholic acid
The two experimental groups will receive reduced dosage of UDCA at 10mg/Kg and 5mg/Kg everyday respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be at least one year.
Also known as: UDCA
Recurrence rate of primary biliary cholangitis
Liver biochemical markers (AST and ALP in U/L, TBIL in umol/L) that restored to normal increase(bilirubin\>1xULN,ALP≥1.5X ULN, AST≥1.5XULN) again is considered to be PBC recurrence according to the Paris II criteria. The rate of recurrence will be described in percent.
Time frame: change from baseline to month3,6,9,12.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: within 6 months after the trial complete
Access criteria: IPD will be shared by Excel within six months after the trial complete with the public
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for May 2025, 64 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ursodeoxycholic Acid
Peking Union Medical College Hospital →