Liver Failure, AcuteNCT03084198
Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
A study testing hiHep Bioartificial Liver Support System in people with Liver Failure, Acute, run by Shanghai East Hospital.
Trial summary
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Failure, Acute
- What is being tested?
- hiHep Bioartificial Liver Support System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight more than 45 kg;
- Age more than 18;
- Diagnosis of ALF;
- Subjects must not be listed for transplant at the time of Enrollment or, if listed, in the opinion of the Investigator are unlikely to be transplanted within 72 hours;
Who cannot join
- Acute clinical symptoms that are likely to result in death within 48 hours;
- Presence of sepsis or septic shock;
- Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer;
- Portal hypertension;
- Liver dysfunction due to trauma;
Trial locations and contacts
No sites are listed yet.
About this study
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Read the detailed description
Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
- Conditions
- Liver Failure, Acute
- Being tested
- hiHep Bioartificial Liver Support System, Standard care for ALF
- Keywords
- Bioartificial Liver, Acute Liver Failure
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hiHep Bioartificial Liver Support SystemProcedure or surgery
Continuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min.
Standard care for ALFProcedure or surgery
A standard of care for subjects with acute liver failure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard care for ALF Receives: Procedure: Standard care for ALF |
| Experimental group | Experimental | Continuous treatment with the hiHep bioartificial liver support system. Receives: Procedure: hiHep Bioartificial Liver Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of ALF subjects
Overall survival in subjects with acute liver failure will be summarized and compared with control subjects through Study Day 28.
Measured: Study Day 1 through Study Day 28
Secondary outcomes (1)
Complication rate
Proportion of subjects who suffer complications caused by bioartificial liver support system
Measured: Study Day 1 through Study Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Shaolin Ma, MD., Principal investigator, Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084198
- Sponsor's protocol ID
- DFSC-2015（CR）-05
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
- ClinicalTrials.gov ID
- NCT03084198
- Acronym / sponsor ID
- DFSC-2015（CR）-05
- Conditions
- Liver Failure, Acute
- Keywords
- Bioartificial Liver, Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Mar 2017 (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 study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Detailed description
Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Standard care for ALFStandard care for ALF |
| Experimental group | Experimental | Procedure: hiHep Bioartificial Liver Support SystemContinuous treatment with the hiHep bioartificial liver support system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Weight more than 45 kg;
- Age more than 18;
- Diagnosis of ALF;
- Subjects must not be listed for transplant at the time of Enrollment or, if listed, in the opinion of the Investigator are unlikely to be transplanted within 72 hours;
Key exclusion criteria (5 listed)
- Acute clinical symptoms that are likely to result in death within 48 hours;
- Presence of sepsis or septic shock;
- Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer;
- Portal hypertension;
- Liver dysfunction due to trauma;
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 |
|---|---|---|
| hiHep Bioartificial Liver Support SystemContinuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min. | Procedure or surgery | Experimental group |
| Standard care for ALFA standard of care for subjects with acute liver failure. | Procedure or surgery | Control group |
Primary outcome
Overall survival of ALF subjects
Time frame: Study Day 1 through Study Day 28
Overall survival in subjects with acute liver failure will be summarized and compared with control subjects through Study Day 28.
1 secondary outcome
Complication rate
Time frame: Study Day 1 through Study Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Liver Failure, Acute
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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. This study is not recruiting at the moment.
Shaolin Ma, MD. principal investigator
Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University
Questions about this trial
What is this clinical trial studying?
A study testing hiHep Bioartificial Liver Support System in people with Liver Failure, Acute, run by Shanghai East Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaolin Ma, MD. (+8613310167499, m_slin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of ALF subjects (time frame: Study Day 1 through Study Day 28). 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 Apr 2017.