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

NCT05989958 | Recruiting Phase 1

• 1 other identifier: HCB-201
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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]

Study Arms (2)

HepaCure

EXPERIMENTAL

Patients will receive Hepacure treatment ffollowing the treatment of DPMAS and LPE

Combination Product: HepaCure

DPMAS and LPE

ACTIVE COMPARATOR

Patients will receive DPMAS and LPE treatment

Device: DPMAS and LPE

Interventions

HepaCure COMBINATION_PRODUCT

HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.

HepaCure

DPMAS and LPE DEVICE

Using DPMAS and LPE for extracorporeal dialysis treatment.

DPMAS and LPE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.
• Age: ≥ 18 years and ≤ 65 years.
• Body weight: ≥ 40kg;
• 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.

You may not qualify if:

• Subjects with primary or metastatic liver cancer.
• 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.
• Serum creatinine was greater than 132.6 μmol/L.
• 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;

Sponsors & Collaborators

• Hexaell Biotech Co., Ltd.: lead

Study Sites (1)

Beijing You&#39;an Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

MeSH Terms

Conditions

Liver Failure; Hepatitis

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• YU Chen, MD

  Beijing YouAn Hospital

  STUDY CHAIR

Central Study Contacts

YU Chen, MD

CONTACT

8610-83997599; chybeyond@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CN (1)