Status:
TERMINATED
Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Non-alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
5311 Patients enrolled
Trial Details
Trial ID
NCT05423327
Start Date
December 9 2021
End Date
October 27 2022
Last Update
March 17 2023
Active Locations (50)
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1
Southern California Research Center
Coronado, California, United States, 92118
2
Velocity Clinical Research
Gardena, California, United States, 90247
3
UCSD Health System
La Jolla, California, United States, 92037-0887
4
National Research Institute
Los Angeles, California, United States, 90057