Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
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|ClinicalTrials.gov Identifier: NCT01875874|
Recruitment Status : Terminated (Due to VTI-208 results, the ELAD clinical plan is being re-evaluated.)
First Posted : June 12, 2013
Results First Posted : August 22, 2018
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Liver Failure Fulminant Hepatic Failure Primary Graft Non-Function Surgically-Induced Liver Failure||Biological: ELAD||Phase 2|
The VTI-212 study (VTI-212) is an open-label, multicenter, historically-controlled study of subjects with acute liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the study will receive ELAD treatment in addition to standard of care treatment for ALF. The outcomes of these subjects will be compared with matched historical controls drawn from existing databases.
Subjects will undergo ELAD treatment for a minimum of 3 days (72 hours). It is recommended ELAD treatment be continued up to 10 days (240 hours).
Following ELAD treatment, subjects will continue standard medical therapy as defined by the institution and be followed through Study Day 28.
Subjects' diagnosis of ALF will be attributed to one of the following:
- Fulminant Hepatic Failure (FHF) (acute liver failure with no preexisting liver disease);
- Primary Graft Non-Function (PNF);
- Surgically-Induced Liver Failure (including subjects with small for size liver transplants, living donor liver transplants, and subjects with risk of ALF following liver cancer surgery.
Screening evaluations and assessments will be completed for subjects and reviewed against inclusion/exclusion criteria.
Enrollment will define the time of study entry (Hour 0, Study Day 1, study baseline) and inclusion in the Intent-to-treat (ITT) population. Subjects will be evaluated throughout the 28-day study period.
If standard medical therapy, as defined by the institution and this protocol is consistent with discharging the subject home, then the subject should be discharged. Prior to discharge, the subject will be advised to attend all follow-up visits.
An extension of this study, the VTI-212E study (VTI-212E), will provide additional ELAD survival data, as available, through VTI-212 study termination (after the last surviving enrolled ELAD subject completes Study Day 28). This registry protocol segment of VTI-212 extends the safety monitoring period to 5 years to assess survival, incidence and characterization of tumor (in particular hepatocellular tumor), incidence of liver transplant, and assess quality of life using a standard, validated questionnaire.
The ITT population includes all randomized subjects assigned to the group to which they were randomized, irrespective of actual treatment administered. Participant, Baseline Characteristics, and Outcome Measures used the ITT population. The safety population is defined as all subjects who are randomized based on actual treatment received. All serious adverse events and all non-serious adverse events analyses used the safety population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2018|
Experimental: ELAD plus standard of care
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
Other Name: Human Cell-Based Bio-Artificial Liver Support System
- Overall Survival (OS) of ALF Subjects [ Time Frame: Study Day 1 through Study Day 28 ]
- Number of Subjects Who Survived at the End of Study Day 28 or Who Received Orthotopic Liver Transplantation on or Before That Study Day. [ Time Frame: Study Day 1 through Study Day 28 ]
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): NCT01875874
|Study Chair:||Jan Stange, MD, Ph.D.||Vital Therapies, Inc.|
|Principal Investigator:||Parvez Mantry, MD||TX - Methodist Dallas Medical Center - The Liver Institute|
|Principal Investigator:||David J Reich, MD||PA - Drexel University College of Medicine|
|Principal Investigator:||Paul J Gaglio, MD||NY - Montefiore Medical Center|
|Principal Investigator:||Juan Gallegos-Orozco, MD||UT - University of Utah|
|Principal Investigator:||Angel Alsina, MD||FL - Tampa General Hospital|
|Principal Investigator:||Lewis W Teperman, MD||NY - New York University Medical Center|
|Principal Investigator:||Nikunj Shah, MD||IL - Rush University Medical Center|
|Principal Investigator:||Julie Thompson, MD||MN - University of Minnesota Medical Center - Twin Cities Campus|
|Principal Investigator:||Winfred W Williams, Jr., MD||MA - Massachusetts General Hospital|
|Principal Investigator:||Lance Stein, MD||GA - Piedmont Atlanta Hospital|
|Principal Investigator:||Ram Subramanian, MD||GA - Emory University Hospital|
|Principal Investigator:||Nikolaos T Pyrsopoulos, MD||NJ - Rutgers University Hospital|
|Principal Investigator:||Marquis Hart, MD||WA - Swedish Medical Center|
|Principal Investigator:||Rohit Satoskar, MD||DC - Georgetown University Hospital|
|Principal Investigator:||Talal Adhami, MD||OH - Cleveland Clinic Foundation|
|Principal Investigator:||Linda S Sher, MD||CA - Keck Hospital of USC|
|Principal Investigator:||Xaralambos Zervos, DO||FL - Cleveland Clinic Florida|
|Principal Investigator:||Kalyan R Bhamidimarri, MD||FL - University of Miami Hospital|