Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT01452295
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.
Study:
NCT01452295
Study Brief:
Protocol Section:
NCT01452295