The staff of CPMI has maintained a population of patients with Hepatic Impairment for a number of years. These patients are divided into two categories; Disease due to alcohol abuse and disease not due to alcohol abuse. NonAlcoholic Steatohepatitis (NASH) is a form of fatty liver disease and not due to alcohol use and the other is known as cirrhotic patients and a direct 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 only by the fact that these subjects are usually quite sick and not able to participate in studies. Historically the size of database varied for this population but averaged between 30 -50 patients at any given time. We have recently began an active outreach and collaboration effort with a group of physicians who are interested in referring this population to us for these trials.
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.
Guidance for Industry
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling