Nonalcoholic Fatty LiverNCT03282305
Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese
An observational study of Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by Great China Fatty Liver Consortium Limited.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese subjects with NAFLD / NASH
Who may be able to join
- 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%.
Who cannot join
- 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)
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- Iron overload disorders (3-4+ iron on liver biopsy or known hemochromatosis gene (HFE) C282Y homozygous with ferritin > 200 ng/ml; note: an elevated ferritin alone is common in NASH and is not exclusionary)
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH) in Chinese
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.
Read the detailed description
GC-FLC is a cooperative consortium of principal investigators from academic institutions and community-based sites treating patients with NAFLD and NASH. The investigators will leverage the multidisciplinary expertise within this network in bio-banking, high-throughput technologies, and biomedical informatics to give investigators the power to analyze effectiveness data at many different levels of resolution, ranging from subsets of patients to very large populations.
GC-FLC will use standardized data collection practices, study data monitoring, and an comprehensive observational protocol in order to increase the efficiency and minimize costs associated with performing clinical research while ensuring collection of detailed critical safety and effectiveness data on prescribed NASH therapies. GC-FLC engages community and academic practice providers as partners in the research to ensure rapid translation of research findings into improvement in healthcare quality and outcomes and to help engage scientists at the interfaces between clinical research and the community. Furthermore, GC-FLC provides the opportunity to pair-comparison between liver biopsy and non-invasive biomarkers in differential low-risk and high-risk population for treatment in real world settings.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological endpoint
The change in NASH Clinical Research Network (CRN) score based on liver biopsy
Measured: 10 years
Secondary outcomes (4)
Number of all-cause death
Number of all-cause death
Measured: 10 years
Number of liver-related death
Number of liver-related death
Measured: 10 years
Number of liver transplant
Number of liver transplant
Measured: 10 years
Number of hepatocellular carcinoma (HCC)
Number of hepatocellular carcinoma (HCC)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startApr 2018 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great China Fatty Liver Consortium Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Wong, MD, PhD, Principal investigator, Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.George Lau, MD, PhD, Study chair, Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong SAR, China.Arun Sanyal, MD, PhD, Study director, Physiology and Molecular Pathology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282305
- Sponsor's protocol ID
- NASH_GC-FLC01
- Status last verified
- Feb 2018
- First submitted
- 12 Sep 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH) in Chinese
- ClinicalTrials.gov ID
- NCT03282305
- Acronym / sponsor ID
- NASH_GC-FLC01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Great China Fatty Liver Consortium LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong, Virginia Commonwealth University
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GC-FLC is a cooperative consortium of principal investigators from academic institutions and community-based sites treating patients with NAFLD and NASH. The investigators will leverage the multidisciplinary expertise within this network in bio-banking, high-throughput technologies, and biomedical informatics to give investigators the power to analyze effectiveness data at many different levels of resolution, ranging from subsets of patients to very large populations.
GC-FLC will use standardized data collection practices, study data monitoring, and an comprehensive observational protocol in order to increase the efficiency and minimize costs associated with performing clinical research while ensuring collection of detailed critical safety and effectiveness data on prescribed NASH therapies. GC-FLC engages community and academic practice providers as partners in the research to ensure rapid translation of research findings into improvement in healthcare quality and outcomes and to help engage scientists at the interfaces between clinical research and the community. Furthermore, GC-FLC provides the opportunity to pair-comparison between liver biopsy and non-invasive biomarkers in differential low-risk and high-risk population for treatment in real world settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese subjects with NAFLD / NASH
Key inclusion criteria (7 listed)
- 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.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%.
Key exclusion criteria (12 listed)
- 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:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological endpoint
Time frame: 10 years
The change in NASH Clinical Research Network (CRN) score based on liver biopsy
4 secondary outcomes
Number of all-cause death
Time frame: 10 years
Number of liver-related death
Time frame: 10 years
Number of liver transplant
Time frame: 10 years
Number of hepatocellular carcinoma (HCC)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Wong, MD, PhD principal investigator
Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.
George Lau, MD, PhD study chair
Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong SAR, China.
Arun Sanyal, MD, PhD study director
Physiology and Molecular Pathology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by Great China Fatty Liver Consortium Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen, Ph.D. (85228184300, chenjing@hnhmgl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological endpoint (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.