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

Sichuan University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis

Treatments: Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone); Drug: Ursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04617561

PBC With AIH Features II

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Ursodeoxycholic Acid group

Active Comparator group

Description:

Ursodeoxycholic Acid 13-15mg/kg/d

Treatment:

Drug: Ursodeoxycholic acid

Ursodeoxycholic Acid+Low Dose Glucocorticoid group

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)