NCT01452295

Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

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• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vital Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Liver Failure

Interventions

Type	Name	Description
DRUG	ELAD (Extracorporeal Liver Assist System)	ELAD (Extracorporeal Liver Assist System)

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-10-14
• Last updated: 2013-12-04