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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis, Autoimmune Primary Biliary Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ursodeoxycholic Acid group

Ursodeoxycholic Acid 13-15mg/kg/d

Group Type ACTIVE_COMPARATOR

Ursodeoxycholic acid

Intervention Type DRUG

Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)

Ursodeoxycholic Acid+Low Dose Glucocorticoid group

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

Group Type EXPERIMENTAL

Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)

Intervention Type DRUG

Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)

Interventions

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Ursodeoxycholic acid

Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)

Intervention Type DRUG

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.)

Intervention Type DRUG

Other Intervention Names

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UDCA;Ursofalk(250mg*25,Losan Pharma GmbH) Medrol（4mg*30,pfizer ltalia srl)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No