VTI-206

• Research type

  Research Study

• Full title

  Efficacy and Safety of the Extacorporeal Liver Assist Device (ELAD) in Subjects with Acute on Chronic Hepatitis (AOCH)

• IRAS ID

  37518

• Contact name

  Rajiv Jalan

• Eudract number

  2009-015002-19

• Clinicaltrials.gov Identifier

  NCT00973817

• Research summary

  Acute on chronic hepatitis (AOCH) is a disease in which an acute insult causes a sudden clinical deterioration of the liver in a person with a previous stable and well compensated liver disease. Most frequent causes of this insult are drugs, alcohol and hepatitis viruses. Even in presence of the best therapeutic options, about 50% of patients with AOCH die due to rapid progression to multiorgan failure. The best treatment for this condition is liver transplantation. However, due to shortage of organs only a small percentage of patients can be transplanted. In the other cases, treatment is only supportive, until liver regenerates and recovers its functional capacity. In this context, it is crucial to support patient liver function as long as possible in order to increase the chance of liver transplantation or liver rigeneration.The ELAD© (Extracorporeal Liver Assist Device) system, developed by Vital Therapies Inc. works as an external artificial liver. It consists of a dialysis-type pump and hollow fiber cartridges populated with an immortalized human liver cell line, the latter redressing one of the major impediments in the development of a biologically active device for use in the treatment of acute hepatic failure.This study evaluates the safety and efficacy of ELAD added to standard medical therapy versus the use of standard medical therapy alone in subjects diagnosed as having AOCH. Approximately 80 subjects will be enrolled in approximately 20 sites between the US and the EU. Enrolled subjects will be randomly (as by tossing a coin) assigned to be treated with either ELAD plus standard therapy or standard therapy alone. The allocation in the two groups will be computer managed (not controllable by the investigators) in a 1 to 1 ratio in order to give to every subject the same chance to be allocate in the ELAD group. All enrolled subjects will be evaluated over a maximum of 93 days.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/96

• Date of REC Opinion

  18 Jan 2010

• REC opinion

  Further Information Favourable Opinion