HepAssis2 ® bioartificial liver system in treating acute‐on‐chronic liver failure patients: Findings from a phase 1 randomised, open‐label clinical trial

HepAssis2 R bioartificial liver system in treating acute-on-chronic liver failure patients: Findings from a phase 1 randomised, open-label clinical trialDear Editor, Acute-on-chronic liver failure (ACLF) carries a grave prognosis of clinical syndrome, with its 28-day mortality reported to be 50%. 1 In China, a high-endemic region for hepatitis B virus (HBV), over 80% of ACLF cases are HBV related. 2 Because of the persistent shortage of donor livers and limited access to timely transplantation, the effective bridging therapies to sustain patients and improve survival are urgently needed.3 Bioartificial liver (BAL) systems represent a promising solution by providing both detoxification and synthetic hepatic functions.4,5 Our research constitutes the first phase 1 randomised, openlabel trial for patients with HBV-ACLF who were treated with the HepAssis2 R BAL system.The system's design (Figure S1) centres on an optimised bioreactor containing the immortalised L-02 human foetal hepatocyte line.6 Ethical approval for this phase 1 trial was granted by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no.2016003).This trial was also formally registered at the Chinese Clinical Trial Registry (ChiCTR2300075781), 40 patients diagnosed with HBV-ACLF were recruited from Zhongnan Hospital of Wuhan University over 2 years (January 2018 to December 2019).The main inclusion criteria are as followed: (1) informed consent from patient/legal guardian; (2) the diagnosis of ACLF was applied according to the following criteria: serum total bilirubin >171 µmol/L (or daily increase ≥17.1 µmol/L) plus prothrombin activity ≤40%; and (3) none of end-stage complications (irreversible respiratory failure, cerebral herniation, sepsis or other severe infections).Using a randomisation schedule generated with SPSS 17.0, the 40 subjects were randomly allocated to two groups in a sequential order of enrollment.One group (N = 17 following exclusions) was treated with the combination of plasma exchange and the dual plasma molecular adsorption system (PE + DPMAS) according to the clinical guidelines for ACLF, and the other received