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

Hexaell Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute on Chronic Hepatic Failure; Hepatitis; Liver Failure

Treatments: Combination Product: HepaCure; Device: DPMAS and LPE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05989958

HCB-201

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

HepaCure

Experimental group

Description:

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

Treatment:

Combination Product: HepaCure

DPMAS and LPE

Active Comparator group

Description:

Patients will receive DPMAS and LPE treatment

Treatment:

Device: DPMAS and LPE