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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODNAS0001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No investigational medicinal product will be administered as a part of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Genetic Variants Associated with NAFLD | Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated. | Up to 8 weeks |
| Liver Fat Content Estimated with Fibroscan | Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (>=) 310 decibels per minute (dB/m) (that is, liver fat >= 10 percent [%]) will be estimated. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Fibrosis Estimated with Fibroscan | Fibroscan will be conducted to obtain liver stiffness measurement to estimate liver fibrosis. Number of participants with absent, low or moderate fibrosis (that is, less than or equal to (<=) 9 kilopascals [kPa]) will be estimated. | Up to 8 weeks |
| Hepatic Fat Fraction |
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Inclusion Criteria:
Exclusion Criteria:
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Participants, who are known to have, or are likely to have, NAFLD.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States | ||
| PRA Health Sciences |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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The liver fat fraction will be obtained by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to estimate the inter-participant variability in liver fat measurement. |
| Up to 8 weeks |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78240 | United States |