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
About this trial
This is an interventional treatment trial for Liver Cirrhosis
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.
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
NCT ID
NCT04727320
First Posted
December 25, 2020
Last Updated
March 7, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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.
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