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Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese

NCT03282305 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2018-02-06

No results posted yet for this study

Summary

Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple steatosis to cirrhosis of the liver. Nonalcoholic fatty liver (NAFL) without substantial hepatocellular injury is thought to be relatively benign whereas nonalcoholic steatohepatitis (NASH) is characterized by hepatocyte steatosis, ballooning, inflammation and varying degrees of fibrosis from none to cirrhosis. NASH is strongly associated with insulin resistance and metabolic syndrome and thus is recognized as a major public health concern as the most prevalent liver disease.

Liver biopsy is the gold standard for a diagnosis of NASH. However, given the large population of patients at risk for NASH, liver biopsy is not a practical method for determining which patients may benefit from NASH therapy. Non-invasive methods to estimate inflammation and fibrosis are in clinical use, but there remains a dichotomy between gold standard inclusion criteria and end points that are utilized in clinical trials and real world diagnostic methods that are more common in clinical practice.

Thus, the investigators would like to conduct an observational study to head-to-head compare the non-invasive methods and liver biopsy in differential liver steatosis and liver biopsy in a real-world setting. Also, by following up patients for a relatively long time (proposed 10 years), the investigators can present the natural history of disease progression.

Conditions

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Great China Fatty Liver Consortium Limited

    lead INDUSTRY

Principal Investigators

  • Vincent Wong, MD, PhD · Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.

  • George Lau, MD, PhD · Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong SAR, China.

  • Arun Sanyal, MD, PhD · Physiology and Molecular Pathology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282305 on ClinicalTrials.gov