Longitudinal Observational Study Of Chinese With NAFLD/NASH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects
Overview
This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.
This study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications in Chinese subjects.
Primary outcome measures
- Prevalence of NAFL/NASH in Chinese [Time frame: up to 10 years]
Secondary outcome measures (3)
- Live imaging analysis [Time frame: up to 10 years]
- Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese [Time frame: up to 10 years]
- Liver histology analysis [Time frame: up to 10 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Humanity and Health Medical Centre — Hong Kong
Identifiers
NCT: NCT03151473 · H&H_NAFLD/NASH study_1