Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT01452295
Status:
WITHDRAWN
Last Update Posted:
2013-12-04
First Post:
2011-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
Sponsor:
Vital Therapies, Inc.
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
The company is also collecting data related to whether a patient received a liver transplant and on survival.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: