NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Verified date | August 2021 |
Source | HepQuant, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination product. Enrollment into one of the 3 Gilead Selonsertib clinical trials (GS-US-416-2124, GS-US-384-1943/1944) is required for enrollment into the HepQuant study
Status | Terminated |
Enrollment | 17 |
Est. completion date | September 11, 2019 |
Est. primary completion date | September 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: The key inclusion criteria for this HepQuant Parallel Study are the inclusion criteria into one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). Once that has been met, subjects must: - Be able to ingest liquid by mouth - Have venous access to support a peripheral IV and 6 blood draws Exclusion Criteria: The key exclusion criteria for this HepQuant Parallel Study are the exclusion criteria for one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). If this has been met, the subject is not eligible to participate in HepQuant. If no exclusion criteria has been met for the Gilead selonsertib trial, ADDITIONAL exclusions for HepQuant are: - Subject should not have had first dose of selonsertib - Subject cannot take anything by mouth - Subject cannot be hypersensitive to eggs, albumin preparations, any ingredient in the formulation, or component of the container - Subject cannot have intercurrent medical or surgical illness (eg: acute MI, acute cerebral hemorrhage, sepsis) - subject cannot have had extensive resection of large segments of small intestine (short gut) - Subject cannot have severe gastroparesis |
Country | Name | City | State |
---|---|---|---|
United States | Methodist Dallas Medical Center | Dallas | Texas |
United States | TX Digestive Disease Consultants | Dallas | Texas |
United States | Schiff Center for Liver Diseases | Miami | Florida |
United States | University of PA | Philadelphia | Pennsylvania |
United States | McGuire VA Med Cntr | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | The Texas Liver Institute | San Antonio | Texas |
United States | University of Washingtion | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
HepQuant, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline DSI | The baseline DSI, or disease severity index, is a measure of severity of liver disease at baseline. The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease). | Baseline | |
Primary | Change in DSI From Baseline to 48 Weeks | Improvement or worsening of liver disease severity from baseline to the week 48 visit as measured by the change in the disease severity index (DSI) (DSI at 48 weeks minus DSI at baseline). The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease). | Baseline and at 48 weeks | |
Secondary | Severity of Liver Disease Index (DSI) Scores Stratified by Baseline NASH CRN Stage of Fibrosis | Compared baseline disease severity index (DSI) scores, which are used to measure severity of liver disease on a scale from 0 (healthy liver) to 50 (severe liver disease), between subjects with F3 or F4 Fibrosis at baseline. Fibrosis stages were obtained clinically using the NASH CRN Scoring System to grade liver biopsy results. This scoring system yields scores ranging from F0 (no fibrosis/healthiest) to F4 (cirrhosis/severe disease). Subjects in this study either had F3 Fibrosis (bridging fibrosis) or F4 Fibrosis (cirrhosis), so F3 subjects have less severe disease than F4 subjects. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
Active, not recruiting |
NCT05479721 -
LITMUS Imaging Study
|
||
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Recruiting |
NCT04976283 -
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT02784444 -
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
|
Phase 2 | |
Not yet recruiting |
NCT05499949 -
The Franciscus Obesity NASH Study
|
||
Completed |
NCT04321343 -
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
Recruiting |
NCT04371042 -
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
|
||
Not yet recruiting |
NCT03648554 -
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
|
Phase 4 | |
Completed |
NCT04972396 -
ALT-801 DDI Study in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03748628 -
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
|
Phase 1 | |
Enrolling by invitation |
NCT05195944 -
Semaglutide vs Sitagliptin
|
Phase 4 | |
Completed |
NCT04643795 -
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
|
Phase 1 | |
Terminated |
NCT03669133 -
Vitamin E for NASH Treatment in HIV Infected Individuals
|
Phase 2 | |
Completed |
NCT04066400 -
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
|
N/A | |
Completed |
NCT03536650 -
Effect of DMR in the Treatment of NASH
|
N/A | |
Completed |
NCT03783897 -
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
|
Phase 1 | |
Completed |
NCT04618744 -
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
Active, not recruiting |
NCT05338034 -
Phase 2a Study of HPG1860 in Subjects With NASH
|
Phase 2 | |
Active, not recruiting |
NCT04653103 -
NASH in Subjects With Different Classes of Obesity
|