Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

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.
 
ClinicalTrials.gov Identifier: NCT04618575
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Li Yang, West China Hospital

Brief Summary:
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1

Condition or disease Intervention/treatment Phase
Hepatitis Primary Biliary Cholangitis Autoimmune Drug: Ursodeoxycholic acid combined with total glucosides of paeony Drug: Ursodeoxycholic acid only Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : November 5, 2022
Estimated Study Completion Date : November 5, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arm Intervention/treatment
Experimental: Ursodeoxycholic acid combined with total glucosides of paeony Drug: Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid combined with total glucosides of paeony

Ursodeoxycholic acid only Drug: Ursodeoxycholic acid only
Ursodeoxycholic acid only




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 24 weeks of treatment, per treatment group.


Secondary Outcome Measures :
  1. Partial remission [ Time Frame: up to 12 months ]
    Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (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. Side-effects [ Time Frame: up to 12 months ]
    Drug related side-effects

  5. Clinical symptoms [ Time Frame: up to 12 months ]
    Jaundice, fatigue, itching, etc

  6. Changes in the proportion of blood immune cells [ Time Frame: up to 12 months ]
    percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 1.0xULN < ALT ≤ 3.0xULN or 1.0xULN < AST ≤ 3.0xULN or 1.0xULN < IgG ≤ 1.3xULN, 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;
  5. Pregnant and breeding women and women of childbearing age in need of reproduction;
  6. Severe disorders of other vital organs, such as severe heart failure, cancer;
  7. Parenteral administration of blood or blood products within 6 months before screening;
  8. Recent treatment with drugs having known liver toxicity;
  9. Taken part in other clinic trials within 6 months before enrollment.

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 ClinicalTrials.gov identifier (NCT number): NCT04618575


Contacts
Layout table for location contacts
Contact: Mengyi Shen, MD +86 15626212342 shenmengyi1219@163.com
Contact: Li Yang, MD +86 13518178110 yangli_hx@scu.edu.cn

Locations
Layout table for location information
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China
Contact: Li Yang, MD    +8618980601276    yangli_hx@scu.edu.cn   
Sponsors and Collaborators
West China Hospital
Investigators
Layout table for investigator information
Study Chair: Li Yang, MD West China Hospital
Layout table for additonal information
Responsible Party: Li Yang, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT04618575    
Other Study ID Numbers: PBC with AIH features 1
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangitis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents