Longitudinal Observational Study Of Chinese With NAFLD/NASH
Recruiting · NCT03151473 · Observational (researchers observe without assigning treatment) · Lead sponsor: Humanity and Health Research Centre
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Humanity and Health Medical Centre - Hong Kong, Hong Kong