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RECRUITING
NCT05989958
PHASE1/PHASE2

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

Sponsor: Hexaell Biotech Co., Ltd.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-09-22

Completion Date

2026-09

Last Updated

2025-02-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing You'an Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China