3.1. Patient population
autoimmune hepatitis, primary biliary cholangitis, biliary cirrhosis, acid-related disorders, liver cancer, hepatoportal sclerosis, hepatic cirrhosis, hepatocellular carcinoma, CLD
AUTOIMMUNE HEPATITIS, BILIARY CIRRHOSIS, PRIMARY BILIARY CHOLANGITIS, LIVER CANCER, CRYPTOGENIC CIRRHOSIS, HEPATIC CIRRHOSIS, HEPATOCELLULAR CARCINOMA, CIRRHOSIS OF THE LIVER, PRIMARY SCLEROSING CHOLANGITIS, CLD
This phase 4 observational registry study was conducted at 43 sites in the USA and was terminated by the sponsor, due to enrollment challenges, prior to completing the planned enrollments. When terminated, 29 of the 43 active sites had screened a total of 65 patients, and 25 of the sites had enrolled a total of 50 patients. Of these 50 patients, 48 were unique patients with 2 patients having been reenrolled into the study and received 2 regimens of avatrombopag for separate procedures, as allowed by the protocol.The overall mean (standard deviation [SD]) age was 61.2 (8.28) years with a higher proportion of males (56%) than females. The enrolled patients had a mean (SD) CTP Grade of 6.7 (1.55) (n = 38) and were of predominantly white racial heritage; full demographics and baseline characteristics are shown in Table Demographics and baseline characteristics.Percentages are based on the number of enrolled patients.SD = standard deviation.Patients may be counted in more than one category.Other etiology of CLD included cryptogenic cirrhosis (n = 4), autoimmune hepatitis (n = 3), hepatic cirrhosis (n = 2), primary sclerosing cholangitis (n = 1), biliary cirrhosis (n = 1), primary biliary cholangitis (n = 1), hepatoportal sclerosis (n = 1) and cirrhosis of the liver (n = 1).Barcelona clinic liver cancer Grade for hepatocellular carcinoma included: Grade 0 (n = 1), Grade A (n = 2), Grade B (n = 1) and unknown (n = 1).All patients completed a 5-day course of once-daily avatrombopag, with 1 (2%) receiving 20 mg (off-label), 27 (54%) receiving 40 mg, and 22 (44%) receiving 60 mg. All patients received at least 1 concomitant medication during the study, which included medications administered during the procedure (41 [82%] receiving a concomitant medication on procedure day) and for the treatment of AEs. Most concomitant medications were within the pharmacological subclasses of anesthetics and drugs for acid-related disorders.