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

Acute Liver Failure Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01452295
• Other study ID #: VTI-207
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 11, 2011
• Last updated: December 3, 2013
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Vital Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Liver Failure
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• ELAD (Extracorporeal Liver Assist System)
ELAD (Extracorporeal Liver Assist System)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vital Therapies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gather data	See previous description	Five years post study participation	Yes