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

NCT04617561 | Unknown Phase 4

• 1 other identifier: PBC With AIH Features II
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis, Autoimmune; Primary Biliary Cholangitis

Keywords

Glucocorticoid; Ursodeoxycholic Acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Partial remission

  up to 12 months

• Minimal response

  up to 12 months

• Treatment failure

  up to 12 months

• ALT,AST,IgG

  baseline and month 3,6,12

• percentage of immune cells

  baseline and month 12

Study Arms (2)

Ursodeoxycholic Acid group

ACTIVE COMPARATOR

Ursodeoxycholic Acid 13-15mg/kg/d

Drug: Ursodeoxycholic acid

Ursodeoxycholic Acid+Low Dose Glucocorticoid group

EXPERIMENTAL

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

Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)

Interventions

Ursodeoxycholic acid DRUG

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

Also known as: UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)

Ursodeoxycholic Acid group

Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) DRUG

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

Also known as: Medrol（4mg*30,pfizer ltalia srl)

Ursodeoxycholic Acid+Low Dose Glucocorticoid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hepatitis, Autoimmune; Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)