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

Primary Purpose

Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HepaCure
Sponsored by
Hexaell Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Hepatic Failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily. Age: ≥ 18 years and ≤ 65 years. Body weight: ≥ 40kg; 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; 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: Subjects with primary or metastatic liver cancer. 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. Pneumonia refer to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (after reasonable antibiotic treatment, there are still Peritonitis manifestations or white blood cells in ascites>0.1 × 10 9/L), etc. 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;

Sites / Locations

  • Beijing You'an Hospital affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HepaCure

Arm Description

Patients will receive Hepacure treatment on top of DPMAS

Outcomes

Primary Outcome Measures

Safety outcome
The adverse events (AE), Serious adverse event (SAE), adverse events of special concern (AESI), and device defects (leakage caused by the quality problem of the plasma biological purification column itself) of the safety paramater will be collected, and the safety and tolerability within 14 days and 28 days will be evaluated from the end of the last treatment

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
October 20, 2023
Sponsor
Hexaell Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05989958
Brief Title
The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure
Official Title
A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects With Acute-On-Chronic Liver Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hexaell Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HepaCure
Arm Type
Experimental
Arm Description
Patients will receive Hepacure treatment on top of DPMAS
Intervention Type
Combination Product
Intervention Name(s)
HepaCure
Intervention Description
HepaCure will be administered in extracorporal dialysis for single dose or multiple doses with different treatment duration on top of DPMAS.
Primary Outcome Measure Information:
Title
Safety outcome
Description
The adverse events (AE), Serious adverse event (SAE), adverse events of special concern (AESI), and device defects (leakage caused by the quality problem of the plasma biological purification column itself) of the safety paramater will be collected, and the safety and tolerability within 14 days and 28 days will be evaluated from the end of the last treatment
Time Frame
28 days after the end of last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily. Age: ≥ 18 years and ≤ 65 years. Body weight: ≥ 40kg; 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; 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: Subjects with primary or metastatic liver cancer. 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. Pneumonia refer to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (after reasonable antibiotic treatment, there are still Peritonitis manifestations or white blood cells in ascites>0.1 × 10 9/L), etc. 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YU Chen, MD
Phone
86-13391663900
Email
chybeyond@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU Chen, MD
Organizational Affiliation
Beijing YouAn Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing You'an Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YU Chen, MD
Phone
+8613391663900
Email
chybeyond@163.com

12. IPD Sharing Statement

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

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