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
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
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
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.