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


Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling by invite only)
Both
Acute Liver Failure

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Trial Information

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


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.


Inclusion Criteria:



- Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Gather data

Outcome Description:

See previous description

Outcome Time Frame:

Five years post study participation

Safety Issue:

Yes

Principal Investigator

Robert A Ashley

Investigator Role:

Study Director

Investigator Affiliation:

Vital Therapies, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

VTI-207

NCT ID:

NCT01452295

Start Date:

June 2010

Completion Date:

October 2015

Related Keywords:

  • Acute Liver Failure
  • liver
  • liver failure
  • acute liver failure
  • ELAD
  • alcoholic hepatitis
  • acute on chronic hepatitis
  • Liver Failure
  • Liver Failure, Acute

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