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NCT Number: NCT03151473

Longitudinal Observational Study Of Chinese With NAFLD/NASH

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanity and Health Medical Centre

Hong Kong, 00852

Location status: Recruiting

Location contact

George Lau, MD

CONTACT

[email protected]

(852)28613777

George Lau, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of NAFL/NASH in Chinese

    Time frame: up to 10 years

    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.

Secondary outcomes

  1. 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.

  2. Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese

    Time frame: up to 10 years

    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.

  3. Liver histology analysis

    Time frame: up to 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yudong Wang, PhD

CONTACT

[email protected]

(852)28613777

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 12, 2017
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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