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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04617561
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : March 22, 2021
Information provided by (Responsible Party):
Li Yang, 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.

Condition or disease Intervention/treatment Phase
Hepatitis, Autoimmune Primary Biliary Cholangitis Drug: Ursodeoxycholic acid Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Arm Intervention/treatment
Active Comparator: Ursodeoxycholic Acid group
Ursodeoxycholic Acid 13-15mg/kg/d
Drug: Ursodeoxycholic acid
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
Other Name: UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)

Experimental: 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
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.)
Other Name: Medrol(4mg*30,pfizer ltalia srl)

Primary Outcome Measures :
  1. Biochemical remission [ Time Frame: 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 :
  1. Partial remission [ Time Frame: up to 12 months ]
    Partial remission, defined as ALT or AST serum levels >1x Upper Limit of Normal (ULN) and <2x ULN

  2. Minimal response [ Time Frame: up to 12 months ]
    Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN

  3. Treatment failure [ Time Frame: up to 12 months ]
    defined as no improvement or increase of ALT or AST serum levels

  4. ALT,AST,IgG [ Time Frame: baseline and month 3,6,12 ]
    serum ALT,AST and IgG levels

  5. percentage of immune cells [ Time Frame: baseline and month 12 ]
    percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT

  6. Side-effects [ Time Frame: up to 12 months ]
    Drug related side-effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04617561

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China, Sichuan
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Li Yang, MD    +86 18980601276   
Contact: Chen Huang    +86 18328089415   
Principal Investigator: Chen Huang         
Sponsors and Collaborators
West China Hospital
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Responsible Party: Li Yang, professor, West China Hospital Identifier: NCT04617561    
Other Study ID Numbers: PBC With AIH Features II
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Yang, West China Hospital:
Ursodeoxycholic Acid
Additional relevant MeSH terms:
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Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Ursodeoxycholic Acid
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal