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

NCT ID: NCT01452295

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Acute Liver Failure

Keywords

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liver liver failure acute liver failure ELAD alcoholic hepatitis acute on chronic hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AOCH patients

Patients with acute on chronic hepatitis

Group Type EXPERIMENTAL

ELAD (Extracorporeal Liver Assist System)

Intervention Type DRUG

ELAD (Extracorporeal Liver Assist System)

AAH patients

Patients with acute alcoholic hepatitis

Group Type EXPERIMENTAL

ELAD (Extracorporeal Liver Assist System)

Intervention Type DRUG

ELAD (Extracorporeal Liver Assist System)

Interventions

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ELAD (Extracorporeal Liver Assist System)

ELAD (Extracorporeal Liver Assist System)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria

* Subjects not participating in the VTI-206 clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vital Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert A Ashley

Role: STUDY_DIRECTOR

Vital Therapies, Inc.

Other Identifiers

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VTI-207

Identifier Type: -

Identifier Source: org_study_id