NCT03087968

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: HepQuant, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main study is a Phase 2, double blind, proof-of-concept, randomized study evaluating the safety, tolerability, and biological activity of GS-4997 in combination with prednisolone, compared to prednisolone alone, in subjects with severe, histologically-confirmed AH. This substudy uses the HepQuant SHUNT Liver Diagnostic test to assess severity of disease at baseline and to track disease progression or improvement over the 24 weeks of the study. The HepQuant SHUNT test will be performed at baseline (Day 1) and at Weeks 1, 2, 4, 12, and 24 regardless of treatment Arm. GS-4997 Dose and Mode of Administration. Subjects will be randomized 1:1 to either: * Treatment Group A: GS-4997 18 mg (1 x 18 mg tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily * Treatment Group B: GS-4997 placebo (1 tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily

Conditions

• Severe Alcoholic Hepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-31
• Primary completion: 2017-09-13
• Completion: 2017-09-13
• First posted: 2017-03-23
• Last updated: 2021-08-30

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study