NCT05423327TerminatedNot Applicable
Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)
Regeneron Pharmaceuticals50 sites in 5 countries5,311 target enrollmentStarted: December 9, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 5,311
- Locations
- 50
- Primary Endpoint
- Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Study Overview
Brief Summary
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •One or more of the following:
- •A prior diagnosis of NASH with a Clinical Research Network (CRN) fibrosis score of F1 to F4 based on liver biopsy
- •Evidence of NAFLD by imaging or liver histology as described in the protocol
- •The possible imaging modalities to assess historic evidence of NAFLD may be based on thresholds as described in the protocol
- •Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)
- •A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:
- •Waistline that measures >35 inches (89 centimeters) for women or >40 inches (102 centimeters) for men
- •Historic fasting triglycerides >150 mg/dL within the prior 6 months
- •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
- •Historic fasting blood glucose >100 mg/dL or on diabetes medication within the prior 6 months
- •Historic blood pressure >130/85 mmHg, or on anti-hypertensive medication within the prior 6 months
Exclusion Criteria
- •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.
- •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]).
- •History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score >
- •History of viral and resolved hepatitis or human immunodeficiency virus (HIV).
- •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
Arms & Interventions
Single Blood Draw
Other
Intervention: No Intervention (Procedure)
Outcomes
Primary Outcomes
Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Time Frame: Day 1
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)
Time Frame: Day 1
Secondary Outcomes
- Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13(Day 1)
- Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13(Day 1)
Investigators
Study Sites (50)
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