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

Primary Biliary Cholangitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617561
• Other study ID #: PBC With AIH Features II
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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 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

Related Conditions & MeSH terms

• Cholangitis
• Hepatitis, Autoimmune
• Primary Biliary Cholangitis

Intervention

Drug:
• Ursodeoxycholic acid
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
• Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)

Locations

Country	Name	City	State
China	Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University	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 treatment, per treatment group.	up to 12 months
Secondary	Partial remission	Partial remission, defined as ALT or 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	ALT,AST,IgG	serum ALT,AST and IgG levels	baseline and month 3,6,12
Secondary	percentage of immune cells	percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT	baseline and month 12
Secondary	Side-effects	Drug related side-effects	up to 12 months