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

Launched by HEXAELL BIOTECH CO., LTD. · Aug 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called HepaCure, which is a type of bio-artificial liver support system. The study aims to see if HepaCure, when used alongside a standard treatment known as DPMAS, is safe and well-tolerated by patients with acute-on-chronic liver failure (ACLF), a serious condition affecting the liver. This trial is taking place in multiple centers across China and is currently recruiting participants who are between 18 and 65 years old, weigh at least 40 kg, and show specific signs of ACLF, such as severe fatigue and jaundice.

Participants in this trial will receive either the new treatment (HepaCure plus DPMAS) or just the standard treatment (DPMAS alone) to compare how well each works. Before joining, candidates will need to understand and sign a consent form. It's important to note that individuals with certain serious conditions, such as liver cancer or severe infections, will not be eligible to participate. If you or a loved one are considering this trial, you can expect to receive close monitoring and care throughout the study.

Gender

ALL

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;