Non-Alcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.
The Liver Incytes system allows for full visualization of the liver with the low cost and portability of ultrasound. It is an adjustable multi-frequency technique, which can show large areas of the organ as volumetric elasticity maps. The device uses the Shear Wave Absolute Vibro-Elastography (S-WAVE) method. The primary objective of the study is to determine the relationship between the elasticity results from Liver Incytes and those of MR Elastography. In addition to stiffness measurements, the relationship between the Liver Incytes attenuation measurements and MR-PDFF will also be evaluated. As secondary objectives, the ability of Liver Incytes to correctly stage patients using MRE as the standard (unless biopsy is available), looking specifically at the ability to measure mild and advanced fibrosis. In additional to performance objectives, the safety, tolerability and usability of the device will be assessed. This is a prospective, open label, validation study of the Liver Incytes system in comparison to MR results (as gold standard) in patients with liver disease or suspected liver disease. Approximately 100 subjects may be enrolled in this study which will take place at clinical centers across Canada and the United States. Study participants should be distributed primarily across the 4 stages of fibrosis, with secondary consideration of the three stages of steatosis. The study is comprised of: Screening Period (up to 28 days) and Data Collection Period. There are no safety follow-up visits in this study. - Screening Period (-28 days to Prior to Imaging (Fibroscan, Liver Incytes, MRE)): during the screening phase, participants will provide written informed consent before undergoing procedures to determine study eligibility. - Data Collection Period (variable duration): Study participants will attend a study visit on Day 1 and may attend an optional visit within 28 days of the initial/Day 1 visit. The total duration of study participation will vary from approximately 2 weeks to approximately 8 weeks. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04481594 -
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT06151964 -
A Trial to Learn How Safe AZD9550 is in People With Type 2 Diabetes Who Are Overweight or Obese
|
Phase 1/Phase 2 | |
Completed |
NCT04019561 -
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
|
Phase 2 | |
Completed |
NCT01694849 -
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
|
Phase 2 | |
Completed |
NCT02653300 -
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
|
Phase 2 | |
Completed |
NCT03517540 -
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
|
Phase 2 | |
Withdrawn |
NCT05050721 -
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
|
||
Enrolling by invitation |
NCT01950884 -
Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis
|
Phase 4 | |
Completed |
NCT04483947 -
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
|
Phase 1 | |
Completed |
NCT02927314 -
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
Active, not recruiting |
NCT02612662 -
A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects
|
Phase 1 | |
Recruiting |
NCT06168383 -
To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .
|
Phase 2 | |
Terminated |
NCT02605616 -
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 2 | |
Completed |
NCT02158351 -
Gut Microbiota and Modulation of Liver Damage in NAFLD
|
||
Recruiting |
NCT03151473 -
Longitudinal Observational Study Of Chinese With NAFLD/NASH
|
||
Recruiting |
NCT04820036 -
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
|
N/A | |
Recruiting |
NCT05553470 -
Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
|
Phase 1 | |
Recruiting |
NCT04639414 -
Combined Active Treatment in Type 2 Diabetes With NASH
|
Phase 4 | |
Withdrawn |
NCT04607655 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT02654665 -
Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults
|
Phase 3 |