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Longitudinal Observational Study Of Chinese With NAFLD/NASH

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ClinicalTrials.gov Identifier: NCT03151473
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Humanity and Health Research Centre

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.

Condition or disease
Non-Alcoholic Fatty Liver Disease (NAFLD) Non-Alcoholic Steatohepatitis (NASH)

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : September 30, 2027





Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Serum/Plasma/Liver biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151473


Contacts
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Contact: Yudong Wang, PhD (852)28613777 danny.wang@hnhmgl.com

Locations
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Hong Kong
Humanity and Health Medical Centre Recruiting
Hong Kong, Hong Kong, 00852
Contact: George Lau, MD    (852)28613777    gkklau@netvigator.com   
Principal Investigator: George Lau, MD         
Sponsors and Collaborators
Humanity and Health Research Centre

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Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT03151473     History of Changes
Other Study ID Numbers: H&H_NAFLD/NASH study_1
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases