Severe Alcoholic Hepatitis Clinical Trial
Official title:
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
Verified date | September 2017 |
Source | HepQuant, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 13, 2017 |
Est. primary completion date | September 13, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Southern California Research Center | Coronado | California |
United States | The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Miami | Miami | Florida |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Intermountain Medical Center | Murray | Utah |
United States | Liver Institute of Virginia | Newport News | Virginia |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Liver Institute of Virginia | Richmond | Virginia |
United States | VCU Health System | Richmond | Virginia |
United States | American Research Corporation at the Texas Liver Institute | San Antonio | Texas |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
HepQuant, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms | Using the SHUNT DSI to evaluate the liver, this outcome will compare the two arms to determine if SHUNT DSI is able to measure a change between the experimental and control groups. | HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24 | |
Secondary | Secondary Outcome 1 | To determine the relationship of baseline Disease Severity Index (DSI) to mortality risk; | HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24 | |
Secondary | Secondary Outcome 2 | To determine the relationship of change in Disease Severity Index (DSI) to mortality risk | HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24 | |
Secondary | Secondary Outcome 3 | To correlate baseline Disease Severity Index (DSI) with baseline Maddrey, MELD, and Lille scorestest with the pharmacokinetics of GS-4997 | HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24 | |
Secondary | Secondary Outcome 4 | To determine the relationship between baseline Disease Severity Index (DSI), Maddrey, MELD, and Lille scores and mortality | HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24 |
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