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

Phase 1

Recruiting

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

• Registration Number: NCT05989958
• Lead Sponsor: Hexaell Biotech Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-4
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Able to communicate effectively with investigators and sign the informed consent<br> form (ICF) voluntarily.<br><br> 2. Age: = 18 years and = 65 years.<br><br> 3. Body weight: = 40kg;<br><br> 4. Met the criteria of ACLF in the early and middle stages in screening period<br> (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on<br> chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by<br> various inducements, manifested as extreme fatigue, with obvious gastrointestinal<br> symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive<br> deepening of jaundice, serum TBil = 171 µmol/L or increase = 17.1 µmol/L daily; with<br> bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%<PTA =<br> 40% (or 1.5 = INR<2.6), and other reasons excluded.<br><br>Exclusion Criteria:<br><br> 1. Subjects with primary or metastatic liver cancer.<br><br> 2. Subjects with severe esophageal/gastric varices and high risk of bleeding, with<br> positive red signs, or with previous active bleeding, as indicated by gastroscopy or<br> imaging examination results.<br><br> 3. Pneumonia refer to the diagnostic criteria of the American Society of Infectious<br> Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal<br> infection (after reasonable antibiotic treatment, there are still Peritonitis<br> manifestations or white blood cells in ascites>0.1 × 10 9/L), etc.<br><br> 4. Subjects with serious uncontrolled infections, including sepsis, septic shock,<br> severe pneumonia (refers to the diagnostic criteria of the American Society of<br> Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007),<br> abdominal infection (exist Peritonitis manifestations or white blood cells in<br> ascites>0.1 × 10 9/L after reasonable antibiotic treatment), etc;

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety outcome