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

Withdrawn before enrolling · Early Phase 1 · Has a placebo group

Conditions studied: Severe Alcoholic Hepatitis

In brief

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.

Key facts

Study ID

NCT03087968

Run by

HepQuant, LLC

People needed

0

Starts

2016-07-31

Expected to finish

2017-09-13

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
• Clinical diagnosis of severe AH
• Maddrey's DF ≥ 32 at screening

You may not qualify if…

• Key Exclusion Criteria:
• Pregnant or lactating females;
• Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
• Serum AST >400 U/L or ALT >300 U/L;
• MELD >30 at screening;
• Maddrey's DF >60 at screening;
• Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
• Concomitant or previous history of hepatocellular carcinoma;
• History of liver transplantation;
• HIV Ab positive;
• Clinical suspicion of pneumonia;
• Uncontrolled sepsis;
• Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
• Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;
• Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
• Portal vein thrombosis;
• Acute pancreatitis;
• Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Where it is running

• Southern California Research Center — Coronado, California, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Liver Institute of Virginia — Newport News, Virginia, United States
• Liver Institute of Virginia — Richmond, Virginia, United States
• VCU Health System — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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