Long-term observation of Chinese patients with fatty liver disease
Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects
This study looks at how Non-Alcoholic Fatty Liver Disease and its more serious form affect Chinese patients over 10 years to learn more about their causes, progression, and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Humanity and Health Research Centre Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03151473 on ClinicalTrials.gov |
What this trial studies
This is a 10-year observational study focusing on patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and its more severe form, Non-Alcoholic Steatohepatitis (NASH). The study aims to address critical clinical questions that remain unanswered from previous trials, exploring the etiology, natural history, diagnosis, treatment, and prevention of these liver conditions. It will also include a biospecimen repository for future translational studies on genomics and biomarkers of response. The research involves a multidisciplinary and multicenter collaboration to gather comprehensive data over the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are being managed or treated for NAFL or NASH.
Not a fit: Patients with significant alcohol consumption, liver cirrhosis, or other chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of NAFLD and NASH, potentially reducing the risk of severe liver complications in patients.
How similar studies have performed: While there have been studies on NAFLD/NASH, this particular longitudinal observational approach focusing on a specific population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or females aged 18 and older; * Adults being managed or treated for NAFL or NASH; * Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent. Exclusion Criteria: * Incompetent to understand and/or sign the informed consent; * Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female; * Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis * Diagnosis of liver cirrhosis and/or hepatocellular carcinoma; * Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFL/NASH.
Where this trial is running
Hong Kong
- Humanity and Health Medical Centre — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Yudong Wang, PhD
- Email: danny.wang@hnhmgl.com
- Phone: (852)28613777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.