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

NCT ID: NCT04618575

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2022-11-05

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

Conditions

Hepatitis; Primary Biliary Cholangitis; Autoimmune

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ursodeoxycholic acid combined with total glucosides of paeony

Group Type: EXPERIMENTAL

Ursodeoxycholic acid combined with total glucosides of paeony

Intervention Type: DRUG

Ursodeoxycholic acid combined with total glucosides of paeony

Ursodeoxycholic acid only

Group Type: OTHER

Ursodeoxycholic acid only

Intervention Type: DRUG

Ursodeoxycholic acid only

Interventions

Ursodeoxycholic acid combined with total glucosides of paeony

Ursodeoxycholic acid combined with total glucosides of paeony

Intervention Type: DRUG

Ursodeoxycholic acid only

Ursodeoxycholic acid only

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yang, MD

Role: STUDY_CHAIR

West China Hospital

Locations

West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mengyi Shen, MD

Role: CONTACT

shenmengyi1219@163.com

+86 15626212342

Li Yang, MD

Role: CONTACT

yangli_hx@scu.edu.cn

+86 13518178110

Facility Contacts

Li Yang, MD

Role: primary

yangli_hx@scu.edu.cn

+8618980601276

Other Identifiers

PBC with AIH features 1

Identifier Type: -

Identifier Source: org_study_id