Longitudinal Observational Study Of Chinese With NAFLD/NASH

Non-Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151473
• Other study ID #: H&H_NAFLD/NASH study_1
• Status: Recruiting
• Start date: May 8, 2017
• Est. completion date: September 30, 2027

Study information

• Verified date: August 2021
• Source: Humanity and Health Research Centre
• Contact: Yudong Wang, PhD
• Phone: (852)28613777
• Email: danny.wang[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: September 30, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Non-Alcoholic Steatohepatitis (NASH)

Locations

Country	Name	City	State
Hong Kong	Humanity and Health Medical Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Humanity and Health Research Centre

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of NAFL/NASH in Chinese	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.	up to 10 years
Secondary	Live imaging analysis	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.	up to 10 years
Secondary	Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese	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.	up to 10 years
Secondary	Liver histology analysis	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.	up to 10 years