RecruitingNCT03151473

Longitudinal Observational Study Of Chinese With NAFLD/NASH

Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects


Sponsor

Humanity and Health Research Centre

Enrollment

20,000 participants

Start Date

May 8, 2017

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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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Locations(1)

Humanity and Health Medical Centre

Hong Kong, Hong Kong

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NCT03151473


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