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
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure, Acute||Procedure: hiHep Bioartificial Liver Support System Procedure: Standard care for ALF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Complication rate [ Time Frame: Study Day 1 through Study Day 60 ]Proportion of subjects who suffer complications caused by bioartificial liver support system
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
|Contact: Shaolin Ma, MD.||+email@example.com|
|Contact: yunhe Zhang, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||Shaolin Ma, MD.||Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University|