Non-alcoholic Steatohepatitis Registry Platform Study (NCT06123858) | Clinical Trial Compass
TerminatedNot Applicable
Non-alcoholic Steatohepatitis Registry Platform Study
Stopped: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion
China1,122 participantsStarted 2023-11-22
Plain-language summary
This is a multi-center, prospective, observational registry platform study aimed at describing the clinical characteristics and diagnosis and treatment patterns of Chinese patients with nonalcoholic steatohepatitis (NASH) with fibrosis.
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
. Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
. FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;
. There are any of the following evidences of fatty liver
. Controlled attenuation parameter (CAP) \> 285 dB/m within 24 months before enrollment;
. Liver ultrasonography showed fatty liver within 24 months before enrollment;
. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) examination within 24 months before enrollment showed liver fat fraction ≥ 5%; and any of the following evidence of liver fibrosis
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
1.Patient demography
Timeframe: Baseline
2
2.The proportion of 4 NASH treatment modalities at baseline and follow-up
Timeframe: up to 3-year follow-up
3
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up
. Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
. The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
Exclusion criteria
. History of liver transplantation;
. Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);