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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04618575
Other study ID # PBC with AIH features 1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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