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

Early Phase 1

• Conditions: Liver Cirrhosis
• Interventions: Drug: Placebo; Drug: Tauroursodeoxycholic acid

• Registration Number: NCT04727320
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-27
• Status Verified: 2021-03
• Study Start: 2021-03-05
• Last Update Submitted: 2021-03-07
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient+placebo	Placebo	-
patient+TUDCA	Tauroursodeoxycholic acid	-

Primary Outcome Measures

Name	Time	Method
Liver biopsy	up to 24 weeks	Synthesis of liver extracellular matrix（Synthesis, degradation）

Secondary Outcome Measures

Name	Time	Method
Liver ultrasound	up to 24 weeks	Liver parenchymal echo（Normal, dense, thickened）