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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Recruitment Status : Withdrawn (Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295))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
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE October 11, 2011
First Posted Date  ICMJE October 14, 2011
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2011)
Gather data [ Time Frame: Five years post study participation ]
See previous description
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Acute Liver Failure
Intervention  ICMJE Drug: ELAD (Extracorporeal Liver Assist System)
ELAD (Extracorporeal Liver Assist System)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
0
Original Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
62
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

  • Subjects not participating in the VTI-206 clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452295
Other Study ID Numbers  ICMJE VTI-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vital Therapies, Inc.
Study Sponsor  ICMJE Vital Therapies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert A Ashley Vital Therapies, Inc.
PRS Account Vital Therapies, Inc.
Verification Date December 2013

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