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

Phase 4

• Conditions: Hepatitis; Primary Biliary Cholangitis; Autoimmune
• Interventions: Drug: Ursodeoxycholic acid only; Drug: Ursodeoxycholic acid combined with total glucosides of paeony

• Registration Number: NCT04618575
• Lead Sponsor: West China Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-06
• Status Verified: 2021-03
• Study Start: 2021-03-17
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-24
• Primary Completion: 2022-11-05
• Study Completion: 2022-11-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic acid only	Ursodeoxycholic acid only	-
Ursodeoxycholic acid combined with total glucosides of paeony	Ursodeoxycholic acid combined with total glucosides of paeony	-

Primary Outcome Measures

Name	Time	Method
Biochemical remission	up to 12 months	The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.

Secondary Outcome Measures

Name	Time	Method
Partial remission	up to 12 months	Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels \>1x Upper Limit of Normal (ULN) and \<2x ULN
Treatment failure	up to 12 months	defined as no improvement or increase of ALT or AST serum levels
Minimal response	up to 12 months	Minimal response, defined as decrease of ALT or AST serum levels but still \>2x ULN
Side-effects	up to 12 months	Drug related side-effects
Clinical symptoms	up to 12 months	Jaundice, fatigue, itching, etc
Changes in the proportion of blood immune cells	up to 12 months	percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China