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

This study has been withdrawn prior to enrollment.
(Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295))
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01452295
First received: October 11, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Acute Liver Failure
Drug: ELAD (Extracorporeal Liver Assist System)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Vital Therapies, Inc.:

Primary Outcome Measures:
  • Gather data [ Time Frame: Five years post study participation ] [ Designated as safety issue: Yes ]
    See previous description


Enrollment: 0
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

  • Subjects not participating in the VTI-206 clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452295

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

No publications provided

Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01452295     History of Changes
Other Study ID Numbers: VTI-207
Study First Received: October 11, 2011
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases

ClinicalTrials.gov processed this record on November 27, 2014