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

NCT05989958 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-02-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hexaell Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • YU Chen, MD · Beijing YouAn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989958 on ClinicalTrials.gov