search
Back to results

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

Primary Purpose

Hepatitis, Autoimmune, Primary Biliary Cholangitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis, Autoimmune focused on measuring Glucocorticoid, Ursodeoxycholic Acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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; Pregnant and breeding women and women of childbearing age in need of reproduction;
  5. Severe disorders of other vital organs, such as severe heart failure, cancer;
  6. Parenteral administration of blood or blood products within 6 months before screening;
  7. Recent treatment with drugs having known liver toxicity;
  8. Taken part in other clinic trials within 6 months before enrollment.
  9. patients with contraindications of glucocorticoid

Sites / Locations

  • Division of Gastroenterology & Hepatology,West China Hospital,Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ursodeoxycholic Acid group

Ursodeoxycholic Acid+Low Dose Glucocorticoid group

Arm Description

Ursodeoxycholic Acid 13-15mg/kg/d

Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period

Outcomes

Primary Outcome Measures

Biochemical remission
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.

Secondary Outcome Measures

Partial remission
Partial remission, defined as ALT or 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
ALT,AST,IgG
serum ALT,AST and IgG levels
percentage of immune cells
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Side-effects
Drug related side-effects

Full Information

First Posted
October 29, 2020
Last Updated
March 17, 2021
Sponsor
West China Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04617561
Brief Title
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
Official Title
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 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 low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Autoimmune, Primary Biliary Cholangitis
Keywords
Glucocorticoid, Ursodeoxycholic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ursodeoxycholic Acid group
Arm Type
Active Comparator
Arm Description
Ursodeoxycholic Acid 13-15mg/kg/d
Arm Title
Ursodeoxycholic Acid+Low Dose Glucocorticoid group
Arm Type
Experimental
Arm Description
Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Other Intervention Name(s)
UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)
Intervention Description
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Other Intervention Name(s)
Medrol(4mg*30,pfizer ltalia srl)
Intervention Description
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
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 treatment, per treatment group.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Partial remission
Description
Partial remission, defined as ALT or 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
ALT,AST,IgG
Description
serum ALT,AST and IgG levels
Time Frame
baseline and month 3,6,12
Title
percentage of immune cells
Description
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Time Frame
baseline and month 12
Title
Side-effects
Description
Drug related side-effects
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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. patients with contraindications of glucocorticoid
Facility Information:
Facility Name
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Phone
+86 18980601276
Email
yangli_hx@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Chen Huang
Phone
+86 18328089415
Email
huangchen0323@163.com
First Name & Middle Initial & Last Name & Degree
Chen Huang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

We'll reach out to this number within 24 hrs