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

NCT04618575 | Unknown Phase 4

• 1 other identifier: PBC with AIH features 1
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Partial remission

  up to 12 months

• Minimal response

  up to 12 months

• Treatment failure

  up to 12 months

• Side-effects

  up to 12 months

• Clinical symptoms

  up to 12 months

Study Arms (2)

Ursodeoxycholic acid combined with total glucosides of paeony

EXPERIMENTAL

Drug: Ursodeoxycholic acid combined with total glucosides of paeony

Ursodeoxycholic acid only

OTHER

Drug: Ursodeoxycholic acid only

Interventions

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

Ursodeoxycholic acid only DRUG

Ursodeoxycholic acid only

Ursodeoxycholic acid only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years;
• 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;
• Agreed to participate in the trial, and assigned informed consent.

You may not qualify if:

• The presence of hepatitis A, B, C, D, or E virus infection;
• Patients with presence of cirrhosis;
• Patients with presence of fulminant liver failure;
• 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;
• Severe disorders of other vital organs, such as severe heart failure, cancer;
• Parenteral administration of blood or blood products within 6 months before screening;
• Recent treatment with drugs having known liver toxicity;
• Taken part in other clinic trials within 6 months before enrollment.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Hepatitis; Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yang, MD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Mengyi Shen, MD

CONTACT

+86 15626212342; shenmengyi1219@163.com

Li Yang, MD

CONTACT

+86 13518178110; yangli_hx@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 6, 2020
• Study Start: March 17, 2021
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)