STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD IN SUBJECTS WITH ACUTE ALCOHOLIC HEPATITIS WHO HAVE FAILED STEROID THERAPY

• Conditions: Acute Alcoholic Hepatitis (AAH); MedDRA version: 16.0Level: PTClassification code 10019755Term: Hepatitis chronic activeSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-001884-21-ES
• Lead Sponsor: VITAL THERAPIES INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Subjects must meet ALL inclusion criteria to be eligible for the study per the VTI-210 Screening Forms:
1. Age ? 18 and < 65 years;
2. Total bilirubin ? 8 mg/dL;
3. A clinical diagnosis of acute alcoholic hepatitis (AAH), which must be confirmed by liver biopsy. (A biopsy is required to be performed as soon as possible in the beginning of the Screening phase.) If possible, a histological sample is to be stored and available for centralized reading;
4. Subject or legally authorized representative must provide Informed Consent for all phases of the study (Screening, Treatment, and 5-year Follow-Up Registry);
5. Subject must be eligible for Standard of Care treatment as defined in the protocol;
6. Subject must have failed steroid therapy according to Lille protocol (Lille score > 0.45) after at least 7 and not more than 9 days of steroid therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects must NOT meet any of the following exclusion criteria to be eligible for the study entry into the Treatment phase:
1. Platelet count < 50,000/mm3;
2. International Normalization Ratio (INR) > 3.0;
3. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptom, etc.) indicated by any of the following:
a. Presence of sepsis or septic shock
b. Positive blood cultures (Bacteremia, Fungemia) within 72 hours prior to randomization
c. Presence of spontaneous bacterial peritonitis during the 2 days prior to randomization
d. Clinical and radiological signs of pneumonia;
4. Evidence of more than one steroid regimen during this episode of liver failure (i.e., subject has been on steroids and either responded or not responded during this admission at investigative or referral site, then retreated);
5. Hospital admission for any episodes of liver decompensation within the past 2 months;
6. On mechanical ventilation;
7. Evidence of hemodynamic instability as defined by the following:
a. Systolic blood pressure < 90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
b. Mean arterial pressure (MAP) < 60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
c. Requirement for escalating doses of vasopressor support prior to Screening; OR
d. Subject at maximum vasopressor dose at Screening (low doses are allowed);
Low dose vasopressor doses are defined as:
Dobutamine: Low doses: 2.5 to 5.0 ?g/kg/min
Dopamine: Low doses: 0.5 to 2 ?g/kg/min
Epinephrine: Low doses: 1 to 2 ?g/kg/min
Norepinephrine: Low doses: 0.01 to 0.02 ?g/kg/min
Phenylephrine: Low doses: 0.05 to 1 ?g/kg/min
8. Evidence of active bleeding or of major hemorrhage defined as requiring ? 2 units packed red blood cells to maintain a stable hemoglobin occurring within 48 hours of Screening;
9. Evidence of variceal bleeding within 7 days of Screening;
10. Evidence of occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction;
11. Evidence by physical exam, history, or laboratory evaluation of significant concomitant disease with expected life expectancy of less than 3 months, including but not limited to:
a. Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease;
b. Cancer that has metastasized or has not yet been treated;
12. Chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
13. Uncontrolled seizures;
14. Positive serologies for viral hepatitis B (HBAgS) or any positive serology for hepatitis C;
15. Pregnancy as determined by ?-human chorionic gonadotropin (HCG) results, or lactation;
16. Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies;
17. Foreseeable eligibility for liver transplant during the 90-day study period
18. Previous liver transplant;
19. Previous participation in a clinical trial involving ELAD;
20. Has a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or local equivalent) or any other Advanced Directive limiting Standard of Care in place;
21. Inability to provide an address for follow-up home health visits.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified