Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Ursodeoxycholic acid; Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
      • Contact: Chen Huang; Phone Number: +86 18328089415; Email: huangchen0323@163.com
      • Principal Investigator: Chen Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged 18-75 years;
2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
3. Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of cirrhosis;
3. Patients with presence of fulminant liver failure;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease; Pregnant and breeding women and women of childbearing age in need of reproduction;
5. Severe disorders of other vital organs, such as severe heart failure, cancer;
6. Parenteral administration of blood or blood products within 6 months before screening;
7. Recent treatment with drugs having known liver toxicity;
8. Taken part in other clinic trials within 6 months before enrollment.
9. patients with contraindications of glucocorticoid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ursodeoxycholic Acid group; Ursodeoxycholic Acid 13-15mg/kg/d	Drug: Ursodeoxycholic acid; Participants received Ursodeoxycholic acid (13-15mg/kg/d po.); Other Names: UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)
Experimental: Ursodeoxycholic Acid+Low Dose Glucocorticoid group; Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period	Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone); Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.); Other Names: Medrol（4mg*30,pfizer ltalia srl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical remission	The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial remission	Partial remission, defined as ALT or AST serum levels >1x Upper Limit of Normal (ULN) and <2x ULN	up to 12 months
Minimal response	Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN	up to 12 months
Treatment failure	defined as no improvement or increase of ALT or AST serum levels	up to 12 months
ALT,AST,IgG	serum ALT,AST and IgG levels	baseline and month 3,6,12
percentage of immune cells	percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT	baseline and month 12
Side-effects	Drug related side-effects	up to 12 months

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Glucocorticoid; Ursodeoxycholic Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Chronic; Fibrosis; Biliary Tract Diseases; Hepatitis; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Hepatitis, Autoimmune; Liver Cirrhosis, Biliary; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Cholagogues and Choleretics; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Ursodeoxycholic Acid; Glucocorticoids
• Other Study ID Numbers: PBC With AIH Features II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No