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Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084198
Recruitment Status : Unknown
Verified April 2017 by Shanghai East Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Shanghai East Hospital

Brief Summary:
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Condition or disease Intervention/treatment Phase
Liver Failure, Acute Procedure: hiHep Bioartificial Liver Support System Procedure: Standard care for ALF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Control group
Standard care for ALF
Procedure: Standard care for ALF
A standard of care for subjects with acute liver failure.

Experimental: Experimental group
Continuous treatment with the hiHep bioartificial liver support system.
Procedure: hiHep Bioartificial Liver Support System
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: Study Day 1 through Study Day 60 ]
    Proportion of subjects who suffer complications caused by bioartificial liver support system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084198


Contacts
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Contact: Shaolin Ma, MD. +8613310167499 m_slin@sina.com
Contact: yunhe Zhang, M.D. +8613917908722 zyhe31@163.com

Sponsors and Collaborators
Shanghai East Hospital
Chinese Academy of Sciences
Investigators
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Principal Investigator: Shaolin Ma, MD. Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT03084198    
Other Study ID Numbers: DFSC-2015(CR)-05
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai East Hospital:
Bioartificial Liver
Acute Liver Failure
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases