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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03084198

Enrollment

Registered

2017-03-20

Start date

2017-06-30

Completion date

2020-06-30

Last updated

2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure, Acute

Keywords

Bioartificial Liver, Acute Liver Failure

Brief summary

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.

Interventions

PROCEDUREhiHep 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.

PROCEDUREStandard care for ALF

A standard of care for subjects with acute liver failure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Overall survival of ALF subjects	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

Measure	Time frame	Description
Complication rate	Study Day 1 through Study Day 60	Proportion of subjects who suffer complications caused by bioartificial liver support system

Contacts

Primary ContactShaolin Ma, MD.

m_slin@sina.com+8613310167499

Backup Contactyunhe Zhang, M.D.

zyhe31@163.com+8613917908722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026