Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Interventions
- Procedure: No Intervention
- Registration Number
- NCT05423327
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5311
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
Key
- 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 >12.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Blood Draw No Intervention -
- Primary Outcome Measures
Name Time Method Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3) Day 1 Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13) Day 1
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (48)
Southern California Research Center
🇺🇸Coronado, California, United States
Velocity Clinical Research
🇺🇸Gardena, California, United States
UCSD Health System
🇺🇸La Jolla, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
Clinnova Research Solutions
🇺🇸Orange, California, United States
FEMZ Clinical Research
🇺🇸Redondo Beach, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Precision Research Institute, Llc
🇺🇸San Diego, California, United States
San Fernando Valley Health Institute
🇺🇸West Hills, California, United States
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Genoma Research Group, Inc.
🇺🇸Miami, Florida, United States
US Associates in Research, LLC
🇺🇸Miami, Florida, United States
Links Clinical Trials
🇺🇸Miami, Florida, United States
Med Research Of Florida, LLC
🇺🇸Miami, Florida, United States
IMIC, Inc
🇺🇸Palmetto Bay, Florida, United States
Revival Research
🇺🇸Palmetto Bay, Florida, United States
Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
Mercy Medical Center, Inc
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Mt. Olympus Medical Research
🇺🇸Houston, Texas, United States
Synergy Group US LLC
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc
🇺🇸Houston, Texas, United States
Epic Medical Research
🇺🇸Red Oak, Texas, United States
American Research Corporation at The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Liver Center of Texas
🇺🇸Plano, Texas, United States
R & H Clinical Research
🇺🇸Stafford, Texas, United States
Centro de Diabetes de Curitiba Ltda
🇧🇷Curitiba, Paraná, Brazil
Hospital de Clínicas de Porto Alegre (HCPA)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷São Paulo, Brazil
IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR
🇧🇷Rio de Janeiro, Brazil
Keimyung University Dongsan Hospital
🇰🇷Dalseo-gu, Daegu, Korea, Republic of
Seoul National University College of Medicine, Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Gyeonggi, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Dongjak-gu, Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Jongno-gu, Seoul, Korea, Republic of
CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
🇲🇽Miguel Hidalgo, Ciudad De México, Mexico
Grupo Médico Terranova - Hospital Terranova
🇲🇽Guadalajara, Jalisco, Mexico
Investigación en Salud y Metabolismo S.C / Nutrición Clínica
🇲🇽Chihuahua, Mexico
Unidad de Atención Médica e Investigación en Salud (UNAMIS)
🇲🇽Mérida, Yucatán, Mexico
Dr. Federico Rodriguez-Perez MD, Office of
🇵🇷San Juan, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Fundación de Investigación de Diego, Inc.
🇵🇷San Juan, Puerto Rico
Dr. Paola Mansilla-Letelier MD, Office of
🇵🇷San Juan, Puerto Rico
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
PCR
🇲🇽Cuautitlán Izcalli, Estado De México, Mexico