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

• Sponsor: Vital Therapies, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01452295
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 27

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Liver Failure	Drug: ELAD (Extracorporeal Liver Assist System)	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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)
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AOCH patients Patients with acute on chronic hepatitis	Drug: ELAD (Extracorporeal Liver Assist System); ELAD (Extracorporeal Liver Assist System)
Experimental: AAH patients Patients with acute alcoholic hepatitis	Drug: ELAD (Extracorporeal Liver Assist System); ELAD (Extracorporeal Liver Assist System)

Outcome Measures

Primary Outcome Measures

1. Gather data [Five years post study participation]

   See previous description

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

• Subjects not participating in the VTI-206 clinical trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vital Therapies, Inc.

Investigators

• Study Director: Robert A Ashley, Vital Therapies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vital Therapies, Inc.
• ClinicalTrials.gov Identifier: NCT01452295
• Other Study ID Numbers: VTI-207
• First Posted: Oct 14, 2011
• Last Update Posted: Dec 4, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Vital Therapies, Inc.: liver; liver failure; acute liver failure; ELAD; alcoholic hepatitis; acute on chronic hepatitis
• Additional relevant MeSH terms: Liver Failure; Hepatic Insufficiency; Liver Failure, Acute

Study Results

No Results Posted as of Dec 4, 2013