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Clinical Trials in China / NCT05989958
Recruiting Phase 1/2

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

NCT05989958 · tracked via the Priya Life Science China tracker
Sponsor
Hexaell Biotech Co., Ltd
Phase
Phase 1/2
Started
2023-09-22
Last updated
2025-02-25

Condition(s) studied

Acute on Chronic Hepatic FailureLiver FailureHepatitis

Investigational drug(s) / intervention(s)

HepaCureDPMAS and LPE

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

DPMAS and LPE: Using DPMAS and LPE for extracorporeal dialysis treatment.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • Safety outcome — From the initiation of treatment until 14 days after the end of study treatment.]
    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）
  • survival rate — 12 weeks after the initial treatment]
    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）

Trial sites (1)

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

Other trials for the same condition

A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) Recruiting
Bidirectional Cohort Study of a Prognosis Model for Acute-on-chronic Liver Failure Active, not recruiting
Registry Study for Optimal Management of Liver Failure in the Chinese Population Recruiting
Fecal Microbiota Transplantation for Liver Failure Recruiting
Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05989958 on ClinicalTrials.gov ↗ ← All trials in China