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

NCT ID: NCT05989958

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HepaCure

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

Group Type: EXPERIMENTAL

HepaCure

Intervention Type: COMBINATION_PRODUCT

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

DPMAS and LPE

Patients will receive DPMAS and LPE treatment

Group Type: ACTIVE_COMPARATOR

DPMAS and LPE

Intervention Type: DEVICE

Using DPMAS and LPE for extracorporeal dialysis treatment.

Interventions

HepaCure

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

Intervention Type: COMBINATION_PRODUCT

DPMAS and LPE

Using DPMAS and LPE for extracorporeal dialysis treatment.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hexaell Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YU Chen, MD

Role: STUDY_CHAIR

Beijing YouAn Hospital

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

YU Chen, MD

Role: CONTACT

chybeyond@163.com

8610-83997599

Facility Contacts

YU Chen, MD

Role: primary

chybeyond@163.com

8610-83997599

Other Identifiers

HCB-201

Identifier Type: -

Identifier Source: org_study_id