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
The company is also collecting data related to whether a patient received a liver transplant
and on survival.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
See previous description
Five years post study participation
Robert A Ashley
Vital Therapies, Inc.
United States: Food and Drug Administration