NCT01452295

Brief Summary

VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

October 11, 2011

Last Update Submit

December 3, 2013

Conditions

Acute Liver Failure

Keywords

liverliver failureacute liver failureELADalcoholic hepatitisacute on chronic hepatitis

Outcome Measures

Primary Outcomes (1)

  • Gather data

    See previous description

    Five years post study participation

Study Arms (2)

AOCH patients

EXPERIMENTAL

Patients with acute on chronic hepatitis

Drug: ELAD (Extracorporeal Liver Assist System)

AAH patients

EXPERIMENTAL

Patients with acute alcoholic hepatitis

Drug: ELAD (Extracorporeal Liver Assist System)

Interventions

ELAD (Extracorporeal Liver Assist System)DRUG

ELAD (Extracorporeal Liver Assist System)

AAH patientsAOCH patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects participating in the VTI-206 clinical trial.

You may not qualify if:

  • Subjects not participating in the VTI-206 clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Failure, AcuteLiver FailureHepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesHepatitisLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Robert A Ashley

    Vital Therapies, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 14, 2011

Study Start

June 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 4, 2013

Record last verified: 2013-12