Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies (NCT06135584) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
1,000 participantsStarted 2023-11-18
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Controlled attenuation parameter (CAP)
Timeframe: Through study completion, an average of 96 week.
2
Transient elastography
Timeframe: Through study completion, an average of 96 week.
3
Model for end-stage liver disease score
Timeframe: Through study completion, an average of 96 week.
4
Portalvein pressure gradient(HVPG)
Timeframe: Through study completion, an average of 96 week.
5
Prevalence of cirrhosis
Timeframe: Through study completion, an average of 96 week.
6
Prevalence of liver transplantation
Timeframe: Through study completion, an average of 96 week.
7
Prevalence of decompensated cirrhosis
Timeframe: Through study completion, an average of 96 week.
Trial details
NCT IDNCT06135584
SponsorThe Affiliated Hospital of Hangzhou Normal University
. 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.