Longitudinal Observational Study Of Chinese With NAFLD/NASH

NCT03151473 | Recruiting DMC

• 1 other identifier: H&H_NAFLD/NASH study_1
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD); Non-Alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Live imaging analysis

  up to 10 years

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

  up to 10 years

• Liver histology analysis

  up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects (BMI ≥ 25 kg/m2) with proven NAFL/NASH either by imaging (using MRI) or histology, referred to secondary or tertiary care for liver related problems will be asked to participate in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead

Study Sites (1)

Humanity and Health Medical Centre

Hong Kong, 00852, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/Plasma/Liver biopsy

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Yudong Wang, PhD

CONTACT

(852)28613777; danny.wang@hnhmgl.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: May 8, 2017
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)