Acute on Chronic Hepatic FailurePhase 1/2NCT05989958
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
A Phase 1/2 study testing HepaCure and DPMAS and LPE in people with Acute on Chronic Hepatic Failure and Liver Failure, run by Hexaell Biotech Co., Ltd. at 1 site in China.
Trial 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）. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis
- What is being tested?
- HepaCure and DPMAS and LPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- 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.
- Serum creatinine was greater than 132.6 μmol/L.
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing You'an Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100069
YU Chen, MD, 8610-83997599, chybeyond@163.com
About this study
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
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
- Conditions
- Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis
- Being tested
- HepaCure, DPMAS and LPE
- Medical subject headings
- Liver Failure, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaCureCombination product
HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE.
DPMAS and LPEDevice
Using DPMAS and LPE for extracorporeal dialysis treatment.
| Study group | Role | What they receive |
|---|---|---|
| HepaCure | Experimental | Patients will receive Hepacure treatment ffollowing the treatment of DPMAS and LPE Receives: Combination Product: HepaCure |
| DPMAS and LPE | Active comparator | Patients will receive DPMAS and LPE treatment Receives: Device: DPMAS and LPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.（Phase I）
Measured: From the initiation of treatment until 14 days after the end of study treatment.]
survival rate
The survival rate without liver transplantation at 12 weeks after the first treatment.（PhaseⅡ） Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. （PhaseⅡ）
Measured: 12 weeks after the initial treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Hepatic FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexaell Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YU Chen, MD, Study chair, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989958
- Sponsor's protocol ID
- HCB-201
- Status last verified
- Feb 2025
- First submitted
- 4 Aug 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05989958
- Acronym / sponsor ID
- HCB-201
- Conditions
- Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hexaell Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HepaCure | Experimental | Combination Product: HepaCurePatients will receive Hepacure treatment ffollowing the treatment of DPMAS and LPE |
| DPMAS and LPE | Active comparator | Device: DPMAS and LPEPatients will receive DPMAS and LPE treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 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.
Key exclusion criteria (4 listed)
- 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.
- Serum creatinine was greater than 132.6 μmol/L.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepaCureHepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE. | Combination product | HepaCure |
| DPMAS and LPEUsing DPMAS and LPE for extracorporeal dialysis treatment. | Device | DPMAS and LPE |
Primary outcome
Safety outcome
Time frame: From the initiation of treatment until 14 days after the end of study treatment.]
Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.（Phase I）
survival rate
Time frame: 12 weeks after the initial treatment]
The survival rate without liver transplantation at 12 weeks after the first treatment.（PhaseⅡ） Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. （PhaseⅡ）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YU Chen, MD study chair
Beijing YouAn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HepaCure and DPMAS and LPE in people with Acute on Chronic Hepatic Failure and Liver Failure, run by Hexaell Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YU Chen, MD (8610-83997599, chybeyond@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: From the initiation of treatment until 14 days after the end of study treatment.]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.