Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

NCT06135584 | Not Yet Recruiting

• 1 other identifier: SMART
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Keywords

Treatment Strategies; Multicenter Real-World Study

Outcome Measures

Primary Outcomes (7)

• Controlled attenuation parameter (CAP)

  Through study completion, an average of 96 week.

• Transient elastography

  Through study completion, an average of 96 week.

• 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.

• Portalvein pressure gradient(HVPG)

  Through study completion, an average of 96 week.

• Prevalence of cirrhosis

  Through study completion, an average of 96 week.

• Prevalence of liver transplantation

  Through study completion, an average of 96 week.

• Prevalence of decompensated cirrhosis

  Through study completion, an average of 96 week.

Study Arms (3)

Pioglitazone metformin tablets

EXPERIMENTAL

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)

Drug: Pioglitazone metformin tablets

Other drug

ACTIVE COMPARATOR

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)

Drug: Other drugs

Drug-free

OTHER

Drug-free

Other: Drug-free

Interventions

Pioglitazone metformin tablets 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)

Pioglitazone metformin tablets

Other drugs DRUG

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

Other drug

Drug-free OTHER

Drug-free

Drug-free

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, gender and ethnicity are not limited;
• Meet the diagnostic criteria for MAFLD;
• F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
• Be willing to sign informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Hangzhou Normal University: lead

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Junping Shi, Doctor

CONTACT

15869151180; 20181580@hznu.edu.cn

Jing Liu

CONTACT

15869151180; 20181580@hznu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 18, 2023
• Study Start: November 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share