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

Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618575
• Other study ID #: PBC with AIH features 1
• Status: Recruiting
• Phase: Phase 4
• Start date: March 17, 2021
• Est. completion date: November 5, 2022

Study information

• Verified date: March 2021
• Source: West China Hospital
• Contact: Mengyi Shen, MD
• Phone: +86 15626212342
• Email: shenmengyi1219[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 137
• Est. completion date: November 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune
• Cholangitis
• Hepatitis
• Primary Biliary Cholangitis

Intervention

Drug:
• Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid combined with total glucosides of paeony
• Ursodeoxycholic acid only
Ursodeoxycholic acid only

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Minimal response	Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN	up to 12 months
Secondary	Treatment failure	defined as no improvement or increase of ALT or AST serum levels	up to 12 months
Secondary	Side-effects	Drug related side-effects	up to 12 months
Secondary	Clinical symptoms	Jaundice, fatigue, itching, etc	up to 12 months
Secondary	Changes in the proportion of blood immune cells	percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT	up to 12 months