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

Phase 4

• Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis
• Interventions: Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone); Drug: Ursodeoxycholic acid

• Registration Number: NCT04617561
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-22
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic Acid+Low Dose Glucocorticoid group	Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)	Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period
Ursodeoxycholic Acid group	Ursodeoxycholic acid	Ursodeoxycholic Acid 13-15mg/kg/d

Primary Outcome Measures

Name	Time	Method
Biochemical remission	up to 12 months	The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.

Secondary Outcome Measures

Name	Time	Method
Minimal response	up to 12 months	Minimal response, defined as decrease of ALT or AST serum levels but still \>2x ULN
Partial remission	up to 12 months	Partial remission, defined as ALT or AST serum levels \>1x Upper Limit of Normal (ULN) and \<2x ULN
Side-effects	up to 12 months	Drug related side-effects
Treatment failure	up to 12 months	defined as no improvement or increase of ALT or AST serum levels
ALT,AST,IgG	baseline and month 3,6,12	serum ALT,AST and IgG levels
percentage of immune cells	baseline and month 12	percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT

Trial Locations

Locations (1)

Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China