Longitudinal Observational Study Of Chinese With NAFLD/NASH

  • STATUS
    Recruiting
  • End date
    Sep 30, 2027
  • participants needed
    20000
  • sponsor
    Humanity and Health Research Centre
Updated on 24 February 2022
Accepts healthy volunteers

Summary

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.

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.

Details
Condition Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH)
Clinical Study IdentifierNCT03151473
SponsorHumanity and Health Research Centre
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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