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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01452295
First received: October 11, 2011
Last updated: October 13, 2011
Last verified: October 2011
History of Changes

October 11, 2011
October 13, 2011
June 2010
October 2015   (final data collection date for primary outcome measure)
Gather data [ Time Frame: Five years post study participation ] [ Designated as safety issue: Yes ]
See previous description
Same as current
Complete list of historical versions of study NCT01452295 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

VTI-207 is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Liver Failure
Drug: ELAD (Extracorporeal Liver Assist System)
ELAD (Extracorporeal Liver Assist System)
  • Experimental: AOCH patients
    Patients with acute on chronic hepatitis
    Intervention: Drug: ELAD (Extracorporeal Liver Assist System)
  • Experimental: AAH patients
    Patients with acute alcoholic hepatitis
    Intervention: Drug: ELAD (Extracorporeal Liver Assist System)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
62
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

  • Subjects not participating in the VTI-206 clinical trial.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01452295
VTI-207
Yes
Vital Therapies, Inc.
Vital Therapies, Inc.
Not Provided
Study Director: Robert A Ashley Vital Therapies, Inc.
Vital Therapies, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP