Registry Protocol for Tracking Trial Subjects After VTI-2... | NCT01452295

Studies
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

NCT01452295

Sponsor

Vital Therapies, Inc.

Status

Withdrawn

Last Update Posted

Dec 4, 2013Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Acute Liver Failure

Interventions

ELAD (Extracorporeal Liver Assist System)

Countries

Not provided

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 11, 2011

First Submission Date that Met QC Criteria

Oct 13, 2011

First Posted Date

Oct 14, 2011Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

Detailed Description

Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.

The company is also collecting data related to whether a patient received a liver transplant and on survival.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ELAD (Extracorporeal Liver Assist System)	Drug	ELAD (Extracorporeal Liver Assist System)	AAH patients AOCH patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gather data	See previous description	Five years post study participation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

Subjects not participating in the VTI-206 clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert A Ashley	Vital Therapies, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D017114	Liver Failure, Acute
D017093	Liver Failure
D006519	Hepatitis, Alcoholic

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D006505	Hepatitis

Browse Leaves

Not provided

Browse Branches

Not provided