Actively Recruiting
Safety, Tolerability and Efficacy Study of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure
Led by Hexaell Biotech Co., Ltd. · Updated on 2025-02-25
92
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a new treatment called HepaCure combined with devices DPMAS and LPE in Chinese patients with acute-on-chronic liver failure (ACLF). This multicenter, randomized, controlled, open-label phase 1/2 clinical study aims to compare HepaCure plus DPMAS to DPMAS alone in patients with this serious liver condition. The study addresses the challenges of ACLF by testing a bio-artificial liver support system to improve patient outcomes. The study consists of two phases. Phase 1 tests the safety and tolerability of single and multiple doses of HepaCure combined with DPMAS in ACLF patients. Phase 2 is randomized and controlled, comparing the effects of HepaCure plus DPMAS and LPE versus DPMAS and LPE alone. HepaCure is delivered through extracorporeal dialysis after patients receive DPMAS and LPE treatments. Two groups receive either HepaCure with DPMAS and LPE or DPMAS and LPE alone. Participants will be monitored from the start of treatment through 14 days after treatment ends for safety outcomes, and survival is followed for 12 weeks after initial treatment. Researchers will assess how well patients tolerate the treatments, their safety, and survival rates. The study lasts up to about three months per participant, with regular evaluations to measure treatment effects and monitor for any adverse events.
CONDITIONS
Brief Title
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate effectively with investigators and voluntarily sign informed consent
- Age between 18 and 65 years
- Body weight of at least 40 kilograms
- Meet criteria for early or middle stage acute-on-chronic liver failure (ACLF) involving chronic liver disease, worsening jaundice, coagulation dysfunction, and gastrointestinal symptoms such as anorexia, vomiting, or abdominal distention
You will not qualify if you...
- Presence of primary or metastatic liver cancer
- Severe esophageal or gastric varices with high bleeding risk, positive red signs, or history of active bleeding
- Serum creatinine level greater than 132.6 micromol/L
- Serious uncontrolled infections including sepsis, septic shock, severe pneumonia, or abdominal infection despite antibiotic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From treatment initiation until 14 days after treatment ends
Participants receive extracorporeal dialysis treatment. Some participants receive HepaCure following DPMAS and LPE treatment, while others receive DPMAS and LPE treatment alone.
Duration - Up to 12 weeks after initial treatment
Participants are monitored for survival and safety outcomes after treatment ends.
Trial Site Locations
Total: 1 location
1
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100069
Actively Recruiting
Research Team
Y
YU Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here