Liver Incytes for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)+1 MoreLiver Incytes - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help assess if a certain kind of liver cell can be used to help diagnose non-alcoholic fatty liver disease and its severity.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Non-Alcoholic Fatty Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: two years

two years
Correlation of Liver Incytes measurements to FibroScan® measurements for liver stiffness and liver steatosis.
Correlation of Liver Incytes measurements to liver biopsy results.
Correlation of Liver Incytes measurements to non-invasive blood markers for predicting advanced fibrosis.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Liver Incytes
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Liver Incytes · No Placebo Group · N/A

Liver Incytes
DiagnosticTest
Experimental Group · 1 Intervention: Liver Incytes · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: two years

Who is running the clinical trial?

Indiana UniversityLead Sponsor
876 Previous Clinical Trials
749,476 Total Patients Enrolled
Sonic IncytesIndustry Sponsor
3 Previous Clinical Trials
404 Total Patients Enrolled
Samer Gawrieh, MD4.67 ReviewsPrincipal Investigator - Indiana University School of Medicine
Indiana University Health, North Hospital, Indiana University Health, University Hospital
Medical School - University of Aleppo Faculty of Medicine, Doctor of Medicine
John H. Stroger, Jr. Hospital of Cook County, Residency in Internal Medicine
2 Previous Clinical Trials
500 Total Patients Enrolled
5Patient Review
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Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person has suspected NAFLD or NASH and is planning to undergo a liver biopsy to confirm the diagnosis.
The person has had a biopsy that proves they have NAFLD or NASH within the last six months.
The text is saying that if someone is enrolled in the study, they will have a liver biopsy within 6 months.
You are able to provide informed consent.