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Recruiting NCT03151473

Longitudinal Observational Study Of Chinese With NAFLD/NASH

Trial Parameters

Condition Non-Alcoholic Fatty Liver Disease (NAFLD)
Sponsor Humanity and Health Research Centre
Study Type OBSERVATIONAL
Phase N/A
Enrollment 20,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2017-05-08
Completion 2027-05-31

Brief 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 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.

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