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

Vital Therapies

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Acute Liver Failure

Treatments: Drug: ELAD (Extracorporeal Liver Assist System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452295

VTI-207

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects participating in the VTI-206 clinical trial.

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

AOCH patients

Experimental group

Description:

Patients with acute on chronic hepatitis

Treatment:

Drug: ELAD (Extracorporeal Liver Assist System)

AAH patients

Experimental group

Description:

Patients with acute alcoholic hepatitis

Treatment:

Drug: ELAD (Extracorporeal Liver Assist System)