Evaluating HepaCure for treating acute-on-chronic liver failure in Chinese patients

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

This study is testing if a new liver support system called HepaCure, used with another treatment, can help Chinese patients with acute-on-chronic liver failure feel better compared to using the other treatment alone.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hexaell Biotech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05989958 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized, controlled, open-label study conducted in China to assess the safety, tolerability, and efficacy of the HepaCure bio-artificial liver support system combined with DPMAS in patients with acute-on-chronic liver failure (ACLF). The study consists of two phases: Phase 1 focuses on evaluating the safety and tolerability of different doses of HepaCure, while Phase 2 aims to compare the efficacy of HepaCure plus DPMAS against DPMAS alone. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese adults aged 18 to 65 with early to middle-stage acute-on-chronic liver failure.

Not a fit: Patients with primary or metastatic liver cancer or severe esophageal/gastric varices may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute-on-chronic liver failure.

How similar studies have performed: While there have been studies on liver support systems, the specific approach of using HepaCure in this context is novel and has not been extensively tested.

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;

Where this trial is running

Beijing, Beijing Municipality

• Beijing You'an Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: YU Chen, MD

Conditions Acute on Chronic Hepatic Failure; Liver Failure; Hepatitis