NCT05989958 The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
| NCT ID | NCT05989958 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hexaell Biotech Co., Ltd. |
| Condition | Acute on Chronic Hepatic Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-09-22 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 92 participants in total. It began in 2023-09-22 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects
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;
Contact & Investigator
YU Chen, MD
STUDY CHAIR
Beijing YouAn Hospital
Frequently Asked Questions
Who can join the NCT05989958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute on Chronic Hepatic Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05989958 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05989958 currently recruiting?
Yes, NCT05989958 is actively recruiting participants. Contact the research team at chybeyond@163.com for enrollment information.
Where is the NCT05989958 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05989958 clinical trial?
NCT05989958 is sponsored by Hexaell Biotech Co., Ltd.. The principal investigator is YU Chen, MD at Beijing YouAn Hospital. The trial plans to enroll 92 participants.