Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

NCT ID: NCT06135584

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-18
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease; Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitazone metformin tablets

Pioglitazone metformin tablets 15mg/500mg (To control the fasting blood glucose below 7.0mmol/l, adjust the dose and dosage according to the blood glucose)

Group Type: EXPERIMENTAL

Pioglitazone metformin tablets

Intervention Type: DRUG

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 drug

Chinese patent medicine or Hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin and GLP1 ((To control the fasting blood glucose below 7.0mmol/l)

Group Type: ACTIVE_COMPARATOR

Other drugs

Intervention Type: DRUG

Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1

Drug-free

Drug-free

Group Type: OTHER

Drug-free

Intervention Type: OTHER

Drug-free

Interventions

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)

Intervention Type: DRUG

Other drugs

Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1

Intervention Type: DRUG

Drug-free

Drug-free

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Junping Shi, Doctor

Role: CONTACT

20181580@hznu.edu.cn

15869151180

Jing Liu

Role: CONTACT

20181580@hznu.edu.cn

15869151180

Other Identifiers

SMART

Identifier Type: -

Identifier Source: org_study_id