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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: YU Chen, MD
• Email: chybeyond@163.com
• Phone: 8610-83997599

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting liver failure after major liver surgery using CT measurements and vascular shape changes

  Doctors are testing whether adding vascular deformation mapping to CT measurements can better predict liver failure after removing a large portion of the liver.

  Recruiting at 3 sites Minia University · Minya, Minya Governorate and 2 other locations · NCT07727759

• Liver transplant with TLI and ATG conditioning to try stopping or reducing immunosuppression

  This trial tests whether a conditioning regimen with Total Lymphoid Irradiation and Anti-Tthymocyte Globulin after a liver transplant can help patients stop or minimize their immunosuppressive drugs over time.

  Recruiting Phase 1/2 Stanford University · Stanford, California · NCT07634562

• ePro Diary for people with HDV (MACROLIVER)

  This project will try a mobile ePro diary app to help adults with Delta hepatitis (HDV) track symptoms and share health information with their care team.

  Recruiting FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Bergamo, Italy · NCT07442760

• Larsucosterol for people with severe alcohol-associated hepatitis

  This trial will test whether larsucosterol helps people with severe alcohol-associated hepatitis survive 90 days without needing a liver transplant.

  Recruiting at 37 sites Phase 3 Bausch Health Americas, Inc. · Birmingham, Alabama and 91 other locations · NCT07428538

• New bioartificial liver for people with liver failure or small-for-size syndrome

  This trial will test a bioartificial liver using hepatocytes made from chemically induced pluripotent stem cells to see if it is safe and tolerated in people with liver failure or small-for-size syndrome.

  Recruiting Phase 1/2 Beijing Friendship Hospital · Beijing · NCT07312864

• CRISPR-edited donor liver transplant to reduce rejection

  This trial will try transplanting deceased-donor livers that have had key HLA genes removed with CRISPR to see if they cause less rejection in adults needing a liver transplant.

  Recruiting Phase 1/2 American Organ Transplant and Cancer Research Institute LLC · Beijing, Changping · NCT07053488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.