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

Sponsored by HepQuant, LLC

About this trial

Last updated 4 years ago

Study ID

HepQuant-002-2124

Status

Withdrawn

Type

Interventional

Phase

Early Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. 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) 2. Clinical diagnosis of severe AH 3. Maddrey's DF ≥ 32 at screening

No

Exclusion Criteria

Key Exclusion Criteria: 1. Pregnant or lactating females; 2. 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; 3. Serum AST >400 U/L or ALT >300 U/L; 4. MELD >30 at screening; 5. Maddrey's DF >60 at screening; 6. Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria; 7. Concomitant or previous history of hepatocellular carcinoma; 8. History of liver transplantation; 9. HIV Ab positive; 10. Clinical suspicion of pneumonia; 11. Uncontrolled sepsis; 12. 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; 13. 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; 14. Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation); 15. Portal vein thrombosis; 16. Acute pancreatitis; 17. Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations

Location

Status