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

NCT06591468 | Enrolling By Invitation Phase 2

• 1 other identifier: KY20242283
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

Primary Biliary Cholangitis; interface hepatitis; Ursodeoxycholic Acid; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with biochemical response

  Alkaline Phosphatase \< 1.67\*ULN

  1 year

Secondary Outcomes (2)

• Assessment of the pruritus and fatigue

  1, 3, 6, 9, and 12 months

• Survival without transplantation and hepatic impairment

  1 year

Study Arms (2)

Prednisone

EXPERIMENTAL

Combination therapy of UDCA (13-15 mg/kg/day) and prednisone. Prednisone 30-40 mg/day, at 7am in the morning, gradually reduced after 1 month (5mg every 7-14 days) to 5-10 mg for maintenance treatment

UDCA

ACTIVE COMPARATOR

UDCA (13-15 mg/kg/day)

Drug: UDCA (Ursodeoxycholic acid)

Interventions

Prednisone DRUG

Prednisone 30-40 mg/day, at 7am in the morning, gradually reduced after 1 month (5mg every 7-14 days) to 5-10 mg for maintenance treatment

UDCA (Ursodeoxycholic acid) DRUG

13-15 mg/kg/day

UDCA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily joining the group, able to understand and sign an informed consent form;
• 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.

You may not qualify if:

• History or presence of other concomitant liver diseases.
• 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.
• Allergic to fenofibrate or ursodeoxycholic acid.
• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
• 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).
• Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
• 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.
• Any other condition(s) that would compromise the safety of the subject or compromise

Sponsors & Collaborators

• Han Ying: lead

Study Sites (2)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Location

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Prednisone; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-06

Locations

CN (2)