- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151473
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
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yudong Wang, PhD
- Phone Number: (852)28613777
- Email: danny.wang@hnhmgl.com
Study Locations
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Hong Kong, Hong Kong, 00852
- Recruiting
- Humanity and Health Medical Centre
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Principal Investigator:
- George Lau, MD
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Contact:
- George Lau, MD
- Phone Number: (852)28613777
- Email: gkklau@netvigator.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of NAFL/NASH in Chinese
Time Frame: up to 10 years
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Determine the prevalence of NAFLD/NASH in military beneficiaries ages 18 or above.
This will be determined by the % of subjects determined to have NAFLD/NASH in Chinese subjects.
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up to 10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live imaging analysis
Time Frame: up to 10 years
|
Transient elastography (FibroScan) and/or MR elastography will provide a measurement of liver stiffness.
The liver stiffness metrics will be tabulated for each of the three time points and assessed for change.
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up to 10 years
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Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese
Time Frame: up to 10 years
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Cytokeratin-18 (CK-18), fibrosis-4 (FIB-4), leptin, adiponectin, TNF-alpha, PAI-1, IL-6, MCP-1, retinoids and other potential biomarkers will be determined and analysed.
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up to 10 years
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Liver histology analysis
Time Frame: up to 10 years
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Liver histology (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up) will be examined and scored.
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up to 10 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H&H_NAFLD/NASH study_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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