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

NCT03282305 | Not Yet Recruiting DMC

• 1 other identifier: NASH_GC-FLC01
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Histological endpoint

  The change in NASH Clinical Research Network (CRN) score based on liver biopsy

  10 years

Secondary Outcomes (4)

• Number of all-cause death

  10 years

• Number of liver-related death

  10 years

• Number of liver transplant

  10 years

• Number of hepatocellular carcinoma (HCC)

  10 years

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese subjects with NAFLD / NASH

You may qualify if:

• Adults and children subjects aged \>= 6 years old
• Ability to understand and sign a written informed consent form (ICF) or provide assent in pediatric subjects
• Diagnosis of NAFLD; or a definite or probable diagnosis of NASH:
• A diagnosis of NAFLD will be defined by evidence of hepatic steatosis, either by imaging or by histology, with no causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steato-genic medication (e.g. valproate, amiodarone, anti-retroviral medications, tetracycline, chronic high-dose corticosteroids), or hereditary disorders (e.g. Wilson's disease, Wolman disease, cholesteryl-ester storage disease);
• A definite diagnosis of NASH will be defined by steatohepatitis confirmed by biopsy with correlating clinical evidence of non-alcoholic liver disease;
• A probable diagnosis of NASH will be defined by:
• a.Elevated alanine amino transferase levels (ALT) of \>40 U/L; and b.Evidence of hepatic steatosis on imaging; or c.Obesity, type 2 diabetes, or pre-diabetes. Pre-diabetes is defined by: i.Impaired fasting glucose: 100 mg/dL-125 mg/dL (5.6 mmol/L-6.9 mmol/L) or; ii.Impaired glucose tolerance: 2-hr plasma glucose (PG) in 75-g Oral Glucose Tolerance Test (OGTT) 140 mg/dL-199 mg/dL (7.8 mmol/L-11.0 mmol/L) or; iii.HbA1C: 5.7%-6.4%.

You may not qualify if:

• Unable to provide written informed consent (or assent in pediatric subjects)
• Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is half pint of beer \[285 mL; 9.64 oz\], 1 glass of spirits \[25 mL; 0.85 oz\] or 1 glass of wine \[125 mL; 4.23 oz\]
• Enrolled in NASH-related clinical trials
• Presence of other forms of chronic liver disease:
• Chronic hepatitis B (HBsAg positive)
• Chronic hepatitis C (HCV RNA positive)
• Autoimmune liver disease (biopsy evidence or clinical diagnosis of autoimmune hepatitis or Primary biliary cholangitis (PBC) requiring ongoing treatment, imaging evidence of Primary sclerosing cholangitis (PSC))
• Wilson's disease
• Alpha-1 antitrypsin mutations that in the opinion of the principal investigator is contributing to the patient's liver disease;
• Prior bariatric surgery unless the surgery was performed more than one year before the biopsy diagnosis of NASH (i.e., NASH is present despite prior bariatric surgery);
• Planned bariatric surgery (e.g. gastroplasty, roux-en-Y gastric bypass).

Sponsors & Collaborators

• Great China Fatty Liver Consortium Limited: lead
• Chinese University of Hong Kong: collaborator
• Virginia Commonwealth University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be stored for biomarkers analysis

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vincent Wong, MD, PhD

  Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.

  PRINCIPAL INVESTIGATOR

• George Lau, MD, PhD

  Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong SAR, China.

  STUDY CHAIR

• Arun Sanyal, MD, PhD

  Physiology and Molecular Pathology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA

  STUDY DIRECTOR

Central Study Contacts

Jing Chen, Ph.D.

CONTACT

85228184300; chenjing@hnhmgl.com

Danny Wang, PhD.

CONTACT

85228184300; danny.wang@hnhmgl.com

Study Design

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

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: April 1, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 6, 2018

Record last verified: 2018-02