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You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
20,000 (estimated)
Sponsor
Humanity and Health Research Centre · Other
Who this trial is looking for
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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.
Trial Locations
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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 i…
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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