The SHUNT-V Study for Varices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03583996|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Liver Disease||Combination Product: HepQuant SHUNT Liver Diagnostic Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects receive HepQuant SHUNT test and DSI measurement prior to a SOC EGD, to be done within 42 days of the SHUNT test. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test|
|Masking:||None (Open Label)|
|Official Title:||The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study|
|Actual Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Open Label
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
Combination Product: HepQuant SHUNT Liver Diagnostic Test
One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test will be completed prior to the EGD. Each subject will receive an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate
- DSI less than/equal to 18.3 [ Time Frame: 1 day ]The primary objective of this study is to measure the subjects' liver function using DSI ≤18.3 for those that are not likely to have large esophageal varices.
- DSI greater than 18.3 [ Time Frame: 1 day ]Secondary objective is to measure the subjects' liver function using DSI >18.3 for those subjects who are likely to have large esophageal varices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583996
|Contact: Andrea Herman, RN, BAemail@example.com|
|Contact: Steve Helmke, PhDfirstname.lastname@example.org|
|United States, Florida|
|Nature Coast Clinical Research||Recruiting|
|Inverness, Florida, United States, 34452|
|Contact: Linda Gray 352-341-2100 email@example.com|
|Principal Investigator: Paul Hellstern, MD|
|Study Director:||Greg Everson, MD||HepQuant, LLC|