ARTICLE | Clinical News

Glycerol phenylbutyrate: Additional Phase II data

March 3, 2014 8:00 AM UTC

Additional data from the double-blind, international Phase II HALT-HE trial in 178 patients with liver cirrhosis and >=2 HE events in the prior 6 months showed that twice-daily 6 mL glycerol phenylbutyrate for 16 weeks met the secondary endpoint of time to first HE event vs. placebo (HR=0.56, p=0.047). Glycerol phenylbutyrate also significantly reduced plasma ammonia levels (46 vs. 58 µmol/L, p=0.04) and the proportion of patients with a Clinical Hepatic Encephalopathy Staging Scale (CHESS) score >=3 points (14% vs. 31%, p=0.02) vs. placebo. Hyperion said plasma ammonia levels correlated with HE events. In 2012, the company reported that the product met the primary endpoint of reducing the proportion of patients experiencing >=1 HE event, as well as other secondary endpoint data from the trial (see BioCentury, June 11, 2012 & Nov. 19, 2012). ...