Phase 2 Evaluation of the ELAD System in the Management o... | NCT00030225

Studies
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

NCT00030225

Sponsor

Vital Therapies, Inc.

Status

Completed

Last Update Posted

Jul 26, 2012Estimated

Enrollment

19Actual

Phase

Phase 2

Conditions

Fulminant Hepatic Failure

Interventions

ELAD
Standard of care (Control)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Feb 2003Actual

Completion Date

Feb 2003Actual

First Submitted Date

Feb 11, 2002

First Submission Date that Met QC Criteria

Feb 11, 2002

First Posted Date

Feb 12, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2012

Last Update Posted Date

Jul 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.

Detailed Description

Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ELAD	Experimental	Treatment with ELAD, extracorporeal liver assist system and standard of care	Biological: ELAD
Standard of care (Control)	Other	Standard of care for patients with fulminant hepatic (liver) failure	Other: Standard of care (Control)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELAD	Biological		ELAD	Extracorporeal Liver Assist Device
Standard of care (Control)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects reaching 30-Day survival	30-day survival	Study Day 30

Secondary Outcomes

Measure	Description	Time Frame
30-day transplant-free survival		Study Day 30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
Weight not less than 40 kilograms
Not listed for organ transplant, but no medical contraindications for transplant

Exclusion Criteria:

Listed for organ transplant at stud entry
History of jaundice for greater than 28 days at screening
Liver dysfunction due to trauma
Concomitant serious disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick J Maguire, MD, PhD	VitaGen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD		San Diego	California	92103	United States
University of Miami

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Millis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation