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

NCT03087968 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2021-08-30

No results posted yet for this study

Summary

This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe Alcoholic Hepatitis. The use of the HepQuant SHUNT test is to assess liver disease severity before, during, and after treatment with GS-4997 or placebo, to assess liver disease severity.

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

Sponsors & Collaborators

  • HepQuant, LLC

    lead INDUSTRY

Principal Investigators

  • Greg Everson, MD · HepQuant, LLC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-09-13
Completion
2017-09-13
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087968 on ClinicalTrials.gov