Health TrialsbyHealthPanel

Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

ConditionsMetabolic Dysfunction-associated Fatty Liver DiseaseCirrhosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Hangzhou Normal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Drug-free

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Pioglitazone metformin tabletsExperimental treatment 1 intervention
Group B: Other drugActive comparator 1 intervention
Group C: Drug-freeOther 1 intervention

Trial outcomes

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

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

Time frame
Through study completion, an average of 96 week.
4

Portalvein pressure gradient(HVPG)

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Hospital of Hangzhou Normal University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: