Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Cirrhosis Clinical Trial

— SMART  

Official title:

Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135584
• Other study ID #: SMART
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 18, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: The Affiliated Hospital of Hangzhou Normal University
• Contact: Junping Shi, Doctor
• Phone: 15869151180
• Email: 20181580[@]hznu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old, gender and ethnicity are not limited;

2. Meet the diagnostic criteria for MAFLD;

3. F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;

4. Be willing to sign informed consent.

Exclusion Criteria:

1. Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);

2. Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;

3. According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).

4. Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.

Related Conditions & MeSH terms

• Cirrhosis
• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases

Intervention

Drug:
• Pioglitazone metformin tablets
Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study)
• Other drugs
Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1

Other:
• Drug-free
Drug-free

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Controlled attenuation parameter (CAP)		Through study completion, an average of 96 week.
Primary	Transient elastography		Through study completion, an average of 96 week.
Primary	Model for end-stage liver disease score	Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores),higher scores mean a worse outcome	Through study completion, an average of 96 week.
Primary	Portalvein pressure gradient(HVPG)		Through study completion, an average of 96 week.
Primary	Prevalence of cirrhosis		Through study completion, an average of 96 week.
Primary	Prevalence of liver transplantation		Through study completion, an average of 96 week.
Primary	Prevalence of decompensated cirrhosis		Through study completion, an average of 96 week.