Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedApril 25, 2017
April 1, 2017
3 years
March 14, 2017
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Day 1 through Study Day 28
Secondary Outcomes (1)
Complication rate
Study Day 1 through Study Day 60
Study Arms (2)
Control group
ACTIVE COMPARATORStandard care for ALF
Experimental group
EXPERIMENTALContinuous treatment with the hiHep bioartificial liver support system.
Interventions
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.
A standard of care for subjects with acute liver failure.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai East Hospitallead
- Chinese Academy of Sciencescollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaolin Ma, MD.
Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 20, 2017
Study Start
June 1, 2017
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share