NCT00558038

Trial name or title	AST‐120 Randomized trial comparing the efficacy of AST‐120 versus lactulose for treatment of mild hepatic encephalopathy
Methods	Open‐label, randomised clinical trial
Participants	End‐stage liver disease with a MELD score < 16 and Grade 1‐2 hepatic encephalopathy (n = 40)
Interventions	AST‐120: 2 g sachets 4 times/day Lactulose: as previously prescribed or started at 30 mL twice and titrated to produce 2‐3 soft stools/day
Outcomes	Primary: change in West Haven grade over 4 weeks Secondary: change in the HESA, ammonia levels, serum bile acid and amino acid profiles, itching (visual analogue scale), asterixis, clinical laboratory tests, clinical examination
Starting date	September 2007
Contact information	Paul Pockros, Scripps Clinic
Country of origin	USA
Notes	Phase 2 study; completed on 30 May 2014