Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124

EARLY_PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2016

Primary Completion Date

September 13, 2017

Study Completion Date

September 13, 2017

Conditions
Severe Alcoholic Hepatitis
Interventions
DRUG

GS-4997

Experimental drug

DRUG

Prednisolone

Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.

DEVICE

HepQuant SHUNT Test

"The HepQuant SHUNT Liver Diagnostic Kit is intended for use in the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The device is indicated to assess the severity of liver disease.~For use by health care professionals. Administer the test under a physician's supervision. The HepQuant Analytical Testing Laboratory must analyze the serum samples."

DRUG

Placebo

Placebo

Trial Locations (13)

19104

University of Pennsylvania, Philadelphia

23226

Liver Institute of Virginia, Richmond

23298

VCU Health System, Richmond

23602

Liver Institute of Virginia, Newport News

30322

Emory University, Atlanta

33136

University of Miami, Miami

39216

University of Mississippi Medical Center, Jackson

55455

University of Minnesota, Minneapolis

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

78215

American Research Corporation at the Texas Liver Institute, San Antonio

84107

Intermountain Medical Center, Murray

92118

Southern California Research Center, Coronado

98104

University of Washington, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HepQuant, LLC

INDUSTRY

NCT03087968 - Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124 | Biotech Hunter | Biotech Hunter