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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Gather data
See previous description
Five years post study participation
Yes
Robert A Ashley
Study Director
Vital Therapies, Inc.
United States: Food and Drug Administration
VTI-207
NCT01452295
June 2010
October 2015
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