Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

Overall Survival
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTL-308E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (28 Aug 2018).
Up to at least Study Day 91, with protocol VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).

Secondary Outcomes (2)

Number of Survivors at Study Day 91
Up to Study Day 91
Number of Subjects With Early Change in Bilirubin Levels at Study Day 7
Up to Study Day 7

Study Arms (2)

ELAD System

EXPERIMENTAL

This group will receive treatment with ELAD plus standard of care therapy.

Biological: ELAD System

Standard of Care (Control)

OTHER

This group will receive standard of care therapy as defined in the protocol.

Other: Standard of Care (Control)

Interventions

ELAD SystemBiological

An extracorporeal human hepatic cell-based liver treatment

Also known as: ELAD

ELAD System

Standard of Care (Control)Other

Standard medical treatment as defined by the protocol

Also known as: Standard of Care

Eligibility Criteria

Age18 Years - 49 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age ≥18;
Total bilirubin ≥16 mg/dL (≥273.6 µmol/L);

Sponsors & Collaborators

Vital Therapies, Inc.
Industrylead

Study Sites (44)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Sharp Coronado Hospital

Coronado, California, 92118, United States

Stanford University Medical Center

Palo Alto, California, 94304, United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, 33136, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Emory University Hospital

Atlanta, Georgia, 30322, United States

Rush University Medical Center

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title: Robert Ashley, Chief Technical Officer
Organization: Vital Therapies, Inc.

Study Officials

Jan Stange, MD
Vital Therapies, Inc.
STUDY DIRECTOR
David Reich, MD
PA - Drexel University
PRINCIPAL INVESTIGATOR
Lance Stein, MD
GA - Piedmont Atlanta Hospital
PRINCIPAL INVESTIGATOR
Nikolaos Pyrsopoulos, MD
NJ - Rutgers University Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

151 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 23, 2015

Study Start

January 2016

Actual (reported)

Study Stopped

Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

ELAD System

Standard of Care (Control)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (44)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Study Stopped

Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

ELAD System

Standard of Care (Control)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (44)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations