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NCT Number: NCT06135584

Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

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.

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Key information

Conditions

Metabolic Dysfunction-Associated Fatty Liver Disease Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

Other drugs

Drug

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

Drug-free

Other

Drug-free

Primary outcomes

  1. Controlled attenuation parameter (CAP)

    Time frame: Through study completion, an average of 96 week.

  2. Transient elastography

    Time frame: Through study completion, an average of 96 week.

  3. Model for end-stage liver disease score

    Time frame: Through study completion, an average of 96 week.

    Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores)，higher scores mean a worse outcome

  4. Portalvein pressure gradient(HVPG)

    Time frame: Through study completion, an average of 96 week.

  5. Prevalence of cirrhosis

    Time frame: Through study completion, an average of 96 week.

  6. Prevalence of liver transplantation

    Time frame: Through study completion, an average of 96 week.

  7. Prevalence of decompensated cirrhosis

    Time frame: Through study completion, an average of 96 week.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Liu

CONTACT

[email protected]

15869151180

Junping Shi, Doctor

CONTACT

[email protected]

15869151180

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Hangzhou Normal University

Other

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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