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

Vital Therapies, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Acute Liver Failure

Interventions

ELAD (Extracorporeal Liver Assist System)DRUG

ELAD (Extracorporeal Liver Assist System)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects participating in the VTI-206 clinical trial. Exclusion Criteria: * Subjects not participating in the VTI-206 clinical trial.

Outcomes

Primary Outcomes

Gather data

See previous description

Time frame: Five years post study participation

Data from ClinicalTrials.gov

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