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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Failure; Hepatitis; Acute on Chronic Hepatic Failure
• Intervention / Treatment: Combination product: HepaCure; Device: DPMAS and LPE

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: YU Chen, MD; Phone Number: 8610-83997599; Email: chybeyond@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Recruiting
      • Beijing You'an Hospital affiliated to Capital Medical University
      • Contact: YU Chen, MD; Phone Number: 8610-83997599; Email: chybeyond@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.
2. Age: ≥ 18 years and ≤ 65 years.
3. Body weight: ≥ 40kg;
4. Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol/L or increase ≥ 17.1 μmol/L daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%<PTA ≤ 40% (or 1.5 ≤ INR<2.6), and other reasons excluded.

Exclusion Criteria:

1. Subjects with primary or metastatic liver cancer.
2. Subjects with severe esophageal/gastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.
3. Serum creatinine was greater than 132.6 μmol/L.
4. Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites>0.1 × 10 9/L after reasonable antibiotic treatment), etc;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HepaCure; Patients will receive Hepacure treatment ffollowing the treatment of DPMAS and LPE	Combination product: HepaCure; HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.
Active Comparator: DPMAS and LPE; Patients will receive DPMAS and LPE treatment	Device: DPMAS and LPE; Using DPMAS and LPE for extracorporeal dialysis treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.（Phase I）	From the initiation of treatment until 14 days after the end of study treatment.]
survival rate	The survival rate without liver transplantation at 12 weeks after the first treatment.（PhaseⅡ） Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. （PhaseⅡ）	12 weeks after the initial treatment]

Collaborators and Investigators

• Sponsor: Hexaell Biotech Co., Ltd.
• Investigators: Study Chair: YU Chen, MD, Beijing Youan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: HCB-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No