Purpose

The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selonsertib + Prednisolone
Selonsertib + prednisolone for 28 days
  • Drug: Selonsertib
    18 mg tablet administered orally once daily
    Other names:
    • GS-4997
  • Drug: Prednisolone
    40 mg (4 x 10 mg tablets) administered orally once daily
Placebo Comparator
Prednisolone
Selonsertib placebo + prednisolone for 28 days
  • Drug: Selonsertib
    18 mg tablet administered orally once daily
    Other names:
    • GS-4997
  • Drug: Prednisolone
    40 mg (4 x 10 mg tablets) administered orally once daily
  • Drug: Placebo
    Selonsertib placebo tablet administered orally once daily

Recruiting Locations

More Details

NCT ID
NCT02854631
Status
Active, not recruiting
Sponsor
Gilead Sciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.