NCT05989958

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

A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Hexaell Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）. Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively. Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects

Conditions

• Acute on Chronic Hepatic Failure
• Liver Failure
• Hepatitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HepaCure	HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.
DEVICE	DPMAS and LPE	Using DPMAS and LPE for extracorporeal dialysis treatment.

Timeline

• Start date: 2023-09-22
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-08-14
• Last updated: 2025-02-25

Locations

1 site across 1 country: China