Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)

NCT05423327 | Terminated

• 1 other identifier: R0000-NASH-CES-2117
• Study Type: interventional
• Target: 5,311
• Locations: 5 countries
• Sites: 50

Brief Summary

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

Conditions

Non-alcoholic Steatohepatitis (NASH)

Keywords

Nonalcoholic fatty liver disease (NAFLD)

Outcome Measures

Primary Outcomes (2)

• Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)

  Day 1

• Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)

  Day 1

Secondary Outcomes (2)

• 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

Study Arms (1)

Single Blood Draw

OTHER

Procedure: No Intervention

Interventions

No Intervention PROCEDURE

Single blood draw

Single Blood Draw

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (50)

Southern California Research Center

Coronado, California, 92118, United States

Location

Velocity Clinical Research

Gardena, California, 90247, United States

Location

UCSD Health System

La Jolla, California, 92037-0887, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Clinnova Research Solutions

Orange, California, 92868, United States

Location

National Research Institute

Panorama City, California, 91402, United States

Location

FEMZ Clinical Research

Redondo Beach, California, 90277, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Precision Research Institute, Llc

San Diego, California, 91910, United States

Location

San Fernando Valley Health Institute

West Hills, California, 91304, United States

Location

Integrity Clinical Research, LLC

Doral, Florida, 33166, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Genoma Research Group, Inc.

Miami, Florida, 33173, United States

Location

US Associates in Research, LLC

Miami, Florida, 33175, United States

Location

Links Clinical Trials

Miami, Florida, 33176, United States

Location

Med Research Of Florida, LLC

Miami, Florida, 33186, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

IMIC, Inc

Palmetto Bay, Florida, 33157, United States

Location

Revival Research

Palmetto Bay, Florida, 33157, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Mercy Medical Center, Inc

Baltimore, Maryland, 21202, United States

Location

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Mt. Olympus Medical Research

Friendswood, Texas, 77546, United States

Location

Mt. Olympus Medical Research

Houston, Texas, 77030, United States

Location

Synergy Group US LLC

Houston, Texas, 77036, United States

Location

Pioneer Research Solutions, Inc

Houston, Texas, 77099, United States

Location

Liver Center of Texas

Plano, Texas, 75026, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

R & H Clinical Research

Stafford, Texas, 77477, United States

Location

Centro de Diabetes de Curitiba Ltda

Curitiba, Paraná, 80810-120, Brazil

Location

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR

Rio de Janeiro, 20241-180, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-000, Brazil

Location

Grupo Médico Terranova - Hospital Terranova

Guadalajara, Jalisco, 44670, Mexico

Location

CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.

Miguel Hidalgo, Mexico City, 11650, Mexico

Location

PCR

Cuautitlán Izcalli, State of Mexico, 54769, Mexico

Location

Unidad de Atención Médica e Investigación en Salud (UNAMIS)

Mérida, Yucatán, 97000, Mexico

Location

Investigación en Salud y Metabolismo S.C / Nutrición Clínica

Chihuahua City, 31110, Mexico

Location

Dr. Federico Rodriguez-Perez MD, Office of

San Juan, 00909, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

VA Caribbean Healthcare System

San Juan, 00921-3201, Puerto Rico

Location

Fundación de Investigación de Diego, Inc.

San Juan, 00927, Puerto Rico

Location

Dr. Paola Mansilla-Letelier MD, Office of

San Juan, 00969, Puerto Rico

Location

Keimyung University Dongsan Hospital

Dalseo-gu, Daegu, 42601, South Korea

Location

Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Hanyang University Seoul Hospital

Seoul, Gyeonggi-do, 04763, South Korea

Location

Chung-Ang University Hospital

Dongjak-gu, Seoul, 06973, South Korea

Location

Seoul National University Hospital

Jongno-gu, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: N/A: No study drug administered

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 21, 2022
• Study Start: December 9, 2021
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

ME (5); BR (5); US (30); KR (5); PR (5)