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

Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01452295

Enrollment

Registered

2011-10-14

Start date

2010-06-30

Completion date

2012-09-30

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Failure

Keywords

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

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.

Interventions

DRUGELAD (Extracorporeal Liver Assist System)

ELAD (Extracorporeal Liver Assist System)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects participating in the VTI-206 clinical trial.

Exclusion criteria

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026