search
Back to results

The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tauroursodeoxycholic acid
Placebo
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment.

Exclusion Criteria:

  • Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    patient+TUDCA

    patient+placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Liver biopsy
    Synthesis of liver extracellular matrix(Synthesis, degradation)

    Secondary Outcome Measures

    Liver ultrasound
    Liver parenchymal echo(Normal, dense, thickened)

    Full Information

    First Posted
    December 25, 2020
    Last Updated
    March 7, 2021
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04727320
    Brief Title
    The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.
    Official Title
    The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 5, 2021 (Anticipated)
    Primary Completion Date
    July 30, 2021 (Anticipated)
    Study Completion Date
    July 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a prospective study. We signed an informed consent form with patients with liver fibrosis and took tauroursodeoxycholic acid orally for half a year. After half a year, liver biopsy was performed using histopathology, immunohistochemistry, and polymerase chain reaction, Western blotting method was used to determine the expression level of fibrosis-related markers to verify the effect of taurodeoxycholic acid on patients with liver fibrosis.
    Detailed Description
    Tauroursodeoxycholic acid is an effective component of bear bile, which has obvious curative effects in the treatment of gallstones and liver diseases. In recent years, the research field of tauroursodeoxycholic acid has been very active, and its chemical synthesis has also attracted much attention. The usage is swallowing with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver biopsy was performed after 6 months. Telling the patient to swallow with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver B-ultrasound biopsy was performed to observe the effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patient+TUDCA
    Arm Type
    Experimental
    Arm Title
    patient+placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Tauroursodeoxycholic acid
    Intervention Description
    Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral placebo, once a day, one tablet at a time for 6 months
    Primary Outcome Measure Information:
    Title
    Liver biopsy
    Description
    Synthesis of liver extracellular matrix(Synthesis, degradation)
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Liver ultrasound
    Description
    Liver parenchymal echo(Normal, dense, thickened)
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment. Exclusion Criteria: Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.

    12. IPD Sharing Statement

    Learn more about this trial

    The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.

    We'll reach out to this number within 24 hrs