Mild to moderate liver fibrosis (F1-F3 stage)
Conditions
Interventions
The taurine deoxycholic acid(TUDCA) treatment group:Taurine deoxycholic acid(TUDCA)
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The participants voluntarily joined this study and signed the informed consent form; 2. When signing the ICF, the age range is 18 to 75 years old, and there is no restriction; on gender. 3. Underwent liver biopsy due to liver diseases (Metavir score F1-F3) and was diagnosed with liver fibrosis.
Exclusion criteria
Exclusion criteria: 1. Cirrhosis (LSM >=15.0 kPa, or confirmed decompensation through clinical, imaging, or endoscopic examination); 2. Other major causes of liver diseases: current infection with hepatitis B or C virus, autoimmune liver disease, Wilson's disease, alpha-1 antitrypsin deficiency, alcohol abuse (more than 30g/day for men, more than 20g/day for women); 3. Liver function with Child-Pugh score of grade B or C; 4. Complicated with liver cancer or other malignant tumors; 5. Complicated with severe heart, lung, or kidney failure; 6. Known to be allergic to taurocholic acid or its excipients; 7. Pregnant, breastfeeding, or planning to have a child during the study and unwilling to take effective contraceptive measures; 8. Using other drugs that may affect the process of liver fibrosis (such as PPAR agonists, etc.), and with unstable dosage; 9. There are other situations that may interfere with the subjects' participation in the study procedures or do not conform to the maximum benefits for the subjects to participate in the study or affect the study results: such as history of mental illness, drug abuse or drug addiction, etc., any other disease or condition with clinical significance (including but not limited to: abnormal laboratory results, active diverticulitis clinically, intra-abdominal abscess, intestinal obstruction, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver stiffness measurement(LSM); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Quality of Life Score;Liver function biochemistry and blood routine tests;Adverse events (AE), serious adverse events (SAE);Four indicators of hepatic fibrosis;Serum Osteopontin (OPN) Levels; | — |
Countries
China
Contacts
Public ContactMing Ni
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed