Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
Primary Purpose
Hepatitis, Primary Biliary Cholangitis, Autoimmune
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid only
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid only
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Partial remission
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Minimal response
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Treatment failure
defined as no improvement or increase of ALT or AST serum levels
Side-effects
Drug related side-effects
Clinical symptoms
Jaundice, fatigue, itching, etc
Changes in the proportion of blood immune cells
percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04618575
Brief Title
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
November 5, 2022 (Anticipated)
Study Completion Date
November 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Primary Biliary Cholangitis, Autoimmune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ursodeoxycholic acid combined with total glucosides of paeony
Arm Type
Experimental
Arm Title
Ursodeoxycholic acid only
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid combined with total glucosides of paeony
Intervention Description
Ursodeoxycholic acid combined with total glucosides of paeony
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid only
Intervention Description
Ursodeoxycholic acid only
Primary Outcome Measure Information:
Title
Biochemical remission
Description
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Partial remission
Description
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Time Frame
up to 12 months
Title
Minimal response
Description
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Time Frame
up to 12 months
Title
Treatment failure
Description
defined as no improvement or increase of ALT or AST serum levels
Time Frame
up to 12 months
Title
Side-effects
Description
Drug related side-effects
Time Frame
up to 12 months
Title
Clinical symptoms
Description
Jaundice, fatigue, itching, etc
Time Frame
up to 12 months
Title
Changes in the proportion of blood immune cells
Description
percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengyi Shen, MD
Phone
+86 15626212342
Email
shenmengyi1219@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yang, MD
Phone
+86 13518178110
Email
yangli_hx@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Phone
+8618980601276
Email
yangli_hx@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
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