Tests prednisone with ursodeoxycholic acid for primary biliary cholangitis liver inflammation
Tests prednisone plus ursodeoxycholic acid in adults with liver-inflammation-related primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Key facts
- Where
- Guangzhou and Xi'an, ChinaSee the 2 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis whose liver biopsy shows moderate to severe interface hepatitis, and who have not yet had UDCA, steroids or other immune-suppressing treatment.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Primary biliary cholangitis confirmed by the AASLD guidelines. Liver biopsy shows moderate to severe interface hepatitis. ALP above 1.67 * ULN, serum ALT below 5 * ULN, serum IgG below 2 * ULN, and a negative anti-smooth muscle antibody test.
- Earlier treatment
- No UDCA, hormone or other immune-suppressing treatment before joining.
- Biomarker or test result
- Diagnosis needs two of three: AMA or gp210 or sp100 positive; raised serum ALP; liver biopsy changes typical of the disease.
Main reasons for not taking part
- Other liver diseases
- ALT or AST above 5×ULN, or TBIL above 3×ULN
- Known pregnancy, positive pregnancy test, or breastfeeding
- Organ transplant recipient, or planned organ transplant
- Needing a liver transplant within 1 year by the Mayo Risk score
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06591468, who can take part
Where in China
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaNo longer taking part
- Xijing hospitalXi'an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Han Ying
- Trial code
- NCT06591468
- Record updated
- 29 October 2026
- Original description
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.Read full original descriptionShow less
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.
Inclusion: Voluntarily joining the group, able to understand and sign an informed consent form; 18 years old ≤ age ≤ 75 years old; The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct; Liver histology suggests moderate to severe interfacial hepatitis (moderate,\<50% portal or fibrous septa destruction, severe,\>50% portal or fibrous septa destruction) with serum ALT\<5 * ULN, serum IgG\<2 * ULN, and negative serum anti smooth muscle antibodies; Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment; ALP\>1.67 * ULN.
Exclusion: History or presence of other concomitant liver diseases; Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users; Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen); Planned to receive an organ transplant or an organ transplant recipient; Needing Liver transplantation within 1 year according to the Mayo Rick score; Allergic to fenofibrate or ursodeoxycholic acid; Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites; Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse); Any other condition(s) that would compromise the safety of the subject or compromise; ALT or AST \> 5×ULN, TBIL \> 3×ULN; If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; Creatinine >1.5×ULN and creatinine clearance <60 ml/min.