Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)

Official Title

Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)

Keywords

Non-alcoholic Steatohepatitis (NASH) Nonalcoholic fatty liver disease (NAFLD) Fatty Liver Non-alcoholic Fatty Liver Disease Single Blood Draw

Eligibility

You can join if…

Open to people ages 18-75

One or more of the following:

  1. A prior diagnosis of NASH with a Clinical Research Network (CRN) fibrosis score of F1 to F4 based on liver biopsy
  2. Evidence of NAFLD by imaging or liver histology as described in the protocol
  3. The possible imaging modalities to assess historic evidence of NAFLD may be based on thresholds as described in the protocol
  4. Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)
  5. A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:
  6. Waistline that measures >35 inches (89 centimeters) for women or >40 inches (102 centimeters) for men
  7. Historic fasting triglycerides >150 mg/dL within the prior 6 months
  8. Historic fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or on cholesterol-lowering medication within the prior 6 months
  9. Historic fasting blood glucose >100 mg/dL or on diabetes medication within the prior 6 months
  10. Historic blood pressure >130/85 mmHg, or on anti-hypertensive medication within the prior 6 months

You CAN'T join if...

  1. Known history or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
  2. Excessive alcohol intake for ≥3 months during the past year prior to screening (>3 units/day for males and >2 units/day for females is generally considered excessive (unit: 1 glass of wine [approximately 125 mL]=1 measure of spirits [approximately 1 fluid ounce]=½ pint of beer [approximately 284 mL]).
  3. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score >12.
  4. History of viral and resolved hepatitis or human immunodeficiency virus (HIV).
  5. Any malignancy within the past 5 years except for basal cell or squamous epithelial cell carcinoma of the skin, or any carcinoma in situ.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Locations

  • UCSD Health System not yet accepting patients
    La Jolla California 92037-0887 United States
  • Southern California Research Center accepting new patients
    Coronado California 92118 United States
  • Precision Research Institute, Llc accepting new patients
    San Diego California 91910 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT05423327
Study Type
Interventional
Participants
Expecting 8000 study participants
Last Updated