Liver Failure, Acute Clinical Trial
Official title:
Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai East Hospital | Chinese Academy of Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complication rate | Proportion of subjects who suffer complications caused by bioartificial liver support system | Study Day 1 through Study Day 60 |
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