Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
- Conditions
- Acute Liver Failure
- Interventions
- Drug: ELAD (Extracorporeal Liver Assist System)
- Registration Number
- NCT01452295
- Lead Sponsor
- Vital Therapies, Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Subjects participating in the VTI-206 clinical trial.
- Subjects not participating in the VTI-206 clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AOCH patients ELAD (Extracorporeal Liver Assist System) Patients with acute on chronic hepatitis AAH patients ELAD (Extracorporeal Liver Assist System) Patients with acute alcoholic hepatitis
- Primary Outcome Measures
Name Time Method Gather data Five years post study participation See previous description
- Secondary Outcome Measures
Name Time Method