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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)

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:

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

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

NCT ID

NCT04617561

First Posted

October 29, 2020

Last Updated

March 17, 2021

Sponsor

West China Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

yangli_hx@scu.edu.cn

First Name & Middle Initial & Last Name & Degree

Chen Huang

Phone

+86 18328089415

huangchen0323@163.com

First Name & Middle Initial & Last Name & Degree

Chen Huang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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