Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
NCT ID: NCT05423327
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
5311 participants
INTERVENTIONAL
2021-12-09
2022-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
NCT04494360
Genetic Studies of Non-Alcoholic Fatty Liver Disease
NCT01629095
Genetics of COVID-19 Susceptibility and Manifestations
NCT04371432
Elevated Serum HDL in Four Generations of a Nashville Family
NCT00525109
Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnancy: A Deep Phenotype Study
NCT05548881
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Blood Draw
No Intervention
Single blood draw
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No Intervention
Single blood draw
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* The possible imaging modalities to assess historic evidence of NAFLD may be based on thresholds as described in the protocol
3. Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)
4. A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:
1. Waistline that measures \>35 inches (89 centimeters) for women or \>40 inches (102 centimeters) for men
2. Historic fasting triglycerides \>150 mg/dL within the prior 6 months
3. 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
4. Historic fasting blood glucose \>100 mg/dL or on diabetes medication within the prior 6 months
5. Historic blood pressure \>130/85 mmHg, or on anti-hypertensive medication within the prior 6 months
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Los Angeles, California, United States
Clinnova Research Solutions
Orange, California, United States
National Research Institute
Panorama City, 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
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
Floridian Clinical Research
Miami Lakes, 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
Friendswood, Texas, 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
Liver Center of Texas
Plano, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
American Research Corporation at The Texas Liver Institute
San Antonio, 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
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda
Porto Alegre, Rio Grande do Sul, Brazil
IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR
Rio de Janeiro, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Grupo Médico Terranova - Hospital Terranova
Guadalajara, Jalisco, Mexico
CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
Miguel Hidalgo, Mexico City, Mexico
PCR
Cuautitlán Izcalli, State of Mexico, Mexico
Unidad de Atención Médica e Investigación en Salud (UNAMIS)
Mérida, Yucatán, Mexico
Investigación en Salud y Metabolismo S.C / Nutrición Clínica
Chihuahua City, , 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
Keimyung University Dongsan Hospital
Dalseo-gu, Daegu, South Korea
Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Hanyang University Seoul Hospital
Seoul, Gyeonggi-do, South Korea
Chung-Ang University Hospital
Dongjak-gu, Seoul, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R0000-NASH-CES-2117
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.