HEPATICALLY IMPAIRED SUBJECT POOL

The staff of CPMI has maintained a population of patients with Hepatic Impairment for a number of years. The size of this population varies but hovers in the 30 -50 patient range at any given time. Most of these patients are cirrhotic patients as a result of alcohol abuse and are classified as either Child-Pugh A or Child-Pugh B. Our ability to recruit Child-Pugh C (severely impaired) patients is limited by the fact that these subjects are usually quite sick and not able to participate in studies. Nevertheless our population of patients has allowed us to complete a number of FDA mandated studies every year according to the guidance that they have published.