Phase 12 Study of HepaCure Plus DPMAS Versus DPMAS Alone for Treating Acute-On-Chronic Liver Failure in Chinese Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a new treatment called HepaCure combined with devices DPMAS and LPE in Chinese patients with acute-on-chronic liver failure ACLF. This multicenter, randomized, controlled, open-label phase 12 clinical study aims to compare HepaCure plus DPMAS to DPMAS alone in patients with this serious liver condition. The study addresses the challenges of ACLF by testing a bio-artificial liver support system to improve patient outcomes. The study consists of two phases. Phase 1 tests the safety and tolerability of single and multiple doses of HepaCure combined with DPMAS in ACLF patients. Phase 2 is randomized and controlled, comparing the effects of HepaCure plus DPMAS and LPE versus DPMAS and LPE alone. HepaCure is delivered through extracorporeal dialysis after patients receive DPMAS and LPE treatments. Two groups receive either HepaCure with DPMAS and LPE or DPMAS and LPE alone. Participants will be monitored from the start of treatment through 14 days after treatment ends for safety outcomes, and survival is followed for 12 weeks after initial treatment. Researchers will assess how well patients tolerate the treatments, their safety, and survival rates. The study lasts up to about three months per participant, with regular evaluations to measure treatment effects and monitor for any adverse events.

The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure