Back to resultsGenetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
Primary Purpose
Non-alcoholic Steatohepatitis (NASH)
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
No Intervention
Sponsored by
About this trial
This is an interventional screening trial for Non-alcoholic Steatohepatitis (NASH) focused on measuring Nonalcoholic fatty liver disease (NAFLD)
Eligibility Criteria
Key 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
Key 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 >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
Sites / Locations
- Southern California Research Center
- Velocity Clinical Research
- UCSD Health System
- National Research Institute
- Clinnova Research Solutions
- National Research Institute
- FEMZ Clinical Research
- Inland Empire Liver Foundation
- Precision Research Institute, Llc
- San Fernando Valley Health Institute
- Integrity Clinical Research, LLC
- Floridian Clinical Research
- Miami Clinical Research
- Genoma Research Group, Inc.
- US Associates in Research, LLC
- Links Clinical Trials
- Med Research Of Florida, LLC
- IMIC, Inc
- Revival Research
- Tandem Clinical Research, LLC
- Mercy Medical Center, Inc
- University of Pennsylvania - Perelman Center for Advanced Medicine
- Mt. Olympus Medical Research
- Mt. Olympus Medical Research
- Synergy Group US LLC
- Pioneer Research Solutions, Inc
- Liver Center of Texas
- Epic Medical Research
- American Research Corporation at The Texas Liver Institute
- R & H Clinical Research
- Centro de Diabetes de Curitiba Ltda
- Hospital de Clínicas de Porto Alegre (HCPA)
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda
- IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR
- Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
- Keimyung University Dongsan Hospital
- Seoul National University College of Medicine, Seoul National University Bundang Hospital
- Hanyang University Seoul Hospital
- Chung-Ang University Hospital
- Seoul National University Hospital
- CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
- PCR
- Grupo Médico Terranova - Hospital Terranova
- Unidad de Atención Médica e Investigación en Salud (UNAMIS)
- Investigación en Salud y Metabolismo S.C / Nutrición Clínica
- Dr. Federico Rodriguez-Perez MD, Office of
- Latin Clinical Trial Center
- VA Caribbean Healthcare System
- Fundación de Investigación de Diego, Inc.
- Dr. Paola Mansilla-Letelier MD, Office of
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Blood Draw
Arm Description
Outcomes
Primary Outcome Measures
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)
Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Secondary Outcome Measures
Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13
Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05423327
Brief Title
Genetic Data Collection in Adult Participants to Identify 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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis (NASH)
Keywords
Nonalcoholic fatty liver disease (NAFLD)
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
N/A: No study drug administered
Masking
None (Open Label)
Allocation
N/A
Enrollment
5311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Blood Draw
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
No Intervention
Intervention Description
Single blood draw
Primary Outcome Measure Information:
Title
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)
Time Frame
Day 1
Title
Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13
Time Frame
Day 1
Title
Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Key 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 >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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Velocity Clinical Research
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
UCSD Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0887
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Clinnova Research Solutions
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
FEMZ Clinical Research
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Precision Research Institute, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
San Fernando Valley Health Institute
City
West Hills
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Floridian Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
US Associates in Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Links Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Med Research Of Florida, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
IMIC, Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Revival Research
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Mercy Medical Center, Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University of Pennsylvania - Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mt. Olympus Medical Research
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Mt. Olympus Medical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Synergy Group US LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Pioneer Research Solutions, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Liver Center of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75026
Country
United States
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
American Research Corporation at The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
R & H Clinical Research
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Facility Name
Centro de Diabetes de Curitiba Ltda
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810-120
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre (HCPA)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Keimyung University Dongsan Hospital
City
Dalseo-gu
State/Province
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Seoul National University College of Medicine, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
State/Province
Gyeonggi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Dongjak-gu
State/Province
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
City
Miguel Hidalgo
State/Province
Ciudad De México
ZIP/Postal Code
11650
Country
Mexico
Facility Name
PCR
City
Cuautitlán Izcalli
State/Province
Estado De México
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Grupo Médico Terranova - Hospital Terranova
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Unidad de Atención Médica e Investigación en Salud (UNAMIS)
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigación en Salud y Metabolismo S.C / Nutrición Clínica
City
Chihuahua
ZIP/Postal Code
31110
Country
Mexico
Facility Name
Dr. Federico Rodriguez-Perez MD, Office of
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
VA Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Fundación de Investigación de Diego, Inc.
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Dr. Paola Mansilla-Letelier MD, Office of
City
San Juan
ZIP/Postal Code
00969
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
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