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

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ClinicalTrials.gov Identifier: NCT01452295
Recruitment Status : Withdrawn (Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295))
First Posted : October 14, 2011
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
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 : June 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

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)

Primary Outcome Measures :
  1. Gather data [ Time Frame: Five years post study participation ]
    See previous description

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452295

Sponsors and Collaborators
Vital Therapies, Inc.
Study Director: Robert A Ashley Vital Therapies, Inc.

Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01452295     History of Changes
Other Study ID Numbers: VTI-207
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Vital Therapies, Inc.:
liver failure
acute liver failure
alcoholic hepatitis
acute on chronic hepatitis

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases