Phase I/II Clinical Trials

Patients in Acute and Acute-on-Chronic liver failure - irrespective of underlying cause or etiology - are to be enrolled in the Phase I/II clinical trial. The primary entrance criterion is hepatic coma progressing beyond Parson's Grade II. Patients will have received or be receiving all standard care for acute liver failure and any attendant multiple organ involvement. Although Phase I/II studies are primarily concerned with safety, data are also collected which might help define efficacy in the future Phase II/III clinical study. This information includes comprehensive metabolic and physiological parameters related to liver failure.

The Phase III or efficacy study will be conducted in 6 centers in the US and involve up to 150 patients. The endpoint will be short-term survival (30 days). Secondary endpoints will comprise a series of physiological and metabolic parameters. In addition to the clinical measurements, patients' quality of life and return to work outcomes will also be measured to compare cost-effectiveness to current treatment options.