Background: ELAD, a human cell-based liver support system, circulates ultrafiltrated patient plasma through a hollow fiber cartridge containing active immortalized C3A human liver cells. Studies have indicated utility of ELAD in cases of severe AOCH, FHF and AHB. Aim: A multicenter, Ph 2, randomized, controlled study evaluated ELAD in acute alcoholic hepatitis (AAH) or acute decompensation of cirrhosis (non-AAH). Methods: Adults with AAH or non-AAH and MELD of 18-35 were randomized 1:1 to standard medical therapy (SMT) + ELAD treatment (ELAD) or SMT. Predefined analyses included all subjects as well as AAH or non-AAH subjects. Results: 62 subjects were randomized; safety data were available for 61. Mean ELAD treatment was 93 (24-144) hrs. Per Protocol (PP) population included 29 AAH subjects (13, ELAD, 16 SMT) who received > 72 hrs treatment with 90 day data.

90-day OS numerically favored AAH subjects in the ELAD group (9/13 vs 7/16, p=0.27). Non-AAH subjects showed the opposite trend (1/6 ELAD vs 6/10 SMT). Liver transplant rates were similar with ELAD (2/19) and SMT (4/26). 18 (62%) ELAD subjects had 31 SAEs and 17 (53%) SMT subjects had 39 SAEs.

4 ELAD subjects had SAEs deemed at least possibly related to ELAD: hematemesis, vaginal bleeding, worsening renal failure, GI hemorrhage, sepsis, and intravascular hemolysis. In the PP analysis, ELAD subjects but not SMT subjects had significant reductions from baseline in total bilirubin during ELAD therapy (days 1, 2, 3 and 4). Mean reduction from baseline for ELAD subjects was 20% at days 3 and 4 p<0.01) while SMT subjects had a mean increase of 4% and 8%, respectively. Categorical analysis based on 10% threshold change from baseline total bilirubin showed significant differences between ELAD and SMT AAH subjects on days 1-4 (p<0.01). Changes in sodium and creatinine were also evaluated.

Teperman, L.: Grant/Research Support, VTI.

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