Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1

Study Overview

• Status: Unknown
• Conditions: Hepatitis; Autoimmune; Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Ursodeoxycholic acid combined with total glucosides of paeony; Drug: Ursodeoxycholic acid only

• Study Type: Interventional
• Enrollment (Anticipated): 137
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mengyi Shen, MD; Phone Number: +86 15626212342; Email: shenmengyi1219@163.com
• Study Contact Backup: Name: Li Yang, MD; Phone Number: +86 13518178110; Email: yangli_hx@scu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 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 1.0xULN < ALT ≤ 3.0xULN or 1.0xULN < AST ≤ 3.0xULN or 1.0xULN < IgG ≤ 1.3xULN, 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;
5. Pregnant and breeding women and women of childbearing age in need of reproduction;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.

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
Experimental: Ursodeoxycholic acid combined with total glucosides of paeony	Drug: Ursodeoxycholic acid combined with total glucosides of paeony; Ursodeoxycholic acid combined with total glucosides of paeony
Other: Ursodeoxycholic acid only	Drug: Ursodeoxycholic acid only; Ursodeoxycholic acid only

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 24 weeks of treatment, per treatment group.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Side-effects	Drug related side-effects	up to 12 months
Partial remission	Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN	up to 12 months
Clinical symptoms	Jaundice, fatigue, itching, etc	up to 12 months
Changes in the proportion of blood immune cells	percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT	up to 12 months

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Anticipated): November 5, 2022
• Study Completion (Anticipated): November 5, 2022

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: October 31, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: PBC with AIH features 1

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