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

• Sponsor: West China Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04618575
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis; Primary Biliary Cholangitis; Autoimmune	Drug: Ursodeoxycholic acid combined with total glucosides of paeony; Drug: Ursodeoxycholic acid only	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 17, 2021
• Anticipated Primary Completion Date: Nov 5, 2022
• Anticipated Study Completion Date: Nov 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Minimal response [up to 12 months]

   Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN

3. Treatment failure [up to 12 months]

   defined as no improvement or increase of ALT or AST serum levels

4. Side-effects [up to 12 months]

   Drug related side-effects

5. Clinical symptoms [up to 12 months]

   Jaundice, fatigue, itching, etc

6. Changes in the proportion of blood immune cells [up to 12 months]

   percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital	Chengdu	Sichuan	China

Sponsors and Collaborators

• West China Hospital

Investigators

• Study Chair: Li Yang, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Yang, Professor, West China Hospital
• ClinicalTrials.gov Identifier: NCT04618575
• Other Study ID Numbers: PBC with AIH features 1
• First Posted: Nov 6, 2020
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholangitis; Liver Cirrhosis, Biliary; Ursodeoxycholic Acid

Study Results

No Results Posted as of Mar 24, 2021