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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200031 / PAS003 |
| Date Original Protocol Accepted |
09/28/2021
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| Date Current Protocol Accepted |
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| Study Name |
OLP New Enrollment PAS
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| Device Name |
Organ Care System (OCS™) Liver
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| Clinical Trial Number(s) |
NCT02522871
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, single-arm, multi-center, new enrollment PAS designed to evaluate the short- and long-term safety and effectiveness of the OCS Liver System for DBD and DCD donor livers preserved on OCS according to the approved indication, in real-world use. The study will include all liver transplant centers in the U.S. that will commercially use the OCS Liver System, with a minimum of 15 participating sites.
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| Study Population |
Adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and eligibility criteria
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| Sample Size |
PAS will enroll the initial 160 sequential adult primary liver transplant recipients who are transplanted with an OCS-perfused DBD or DCD donor liver according to the approved indication (primary analysis population). If the initial 160 transplant recipients does not include at least 60 DCD donor liver transplants, PAS will continue to enroll only DCD donor liver recipients until 60 DCD patients have been enrolled.
For the primary endpoint (1-year patient and graft survival), a sample size of 107 subjects provides 80% power (with a one-sided alpha of 0.05).
For the safety endpoint (6-month graft survival), a sample size of 70 subjects provides 80% power (with a one-sided alpha of 0.05).
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| Key Study Endpoints |
Primary Endpoint: 1-year patient and graft survival post-transplant
Safety Endpoint: 6-month liver graft survival post-transplant
Other Clinical Endpoints:
Incidence of ischemic, non-anastomotic biliary complications through 1-year post-transplant
Incidence of non-ischemic, anastomotic biliary complications through 6 months post-transplant
Kaplan-Meier patient survival at 1- and 2-years
Kaplan-Meier graft survival at 6 months, 1- and 2-years
Collection of OCS Liver Related Data:
OCS Liver perfusion parameters (hepatic artery flow and pressure, portal vein flow and pressure, perfusate temperature, perfusate hematocrit, perfusate venous saturation)
OCS Liver perfusion lactate levels
OCS Liver perfusate pH values
Total bile volume at end of OCS liver perfusion
Incidence of and clinical reasons for donor liver turndown
Incidence and reasons for conversion to cold storage
Device malfunctions
Utilization rate
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| Follow-up Visits and Length of Follow-up |
2 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
As of the date of database closure, 166 patients have been enrolled in the OLP Registry.
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| Actual Number of Sites Enrolled |
Nine sites have been initiated and enrolled patients into the OLP Registry.
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| Patient Follow-up Rate |
Of the 166 subjects enrolled, 158 completed the 24- month visit and are still alive. There were 8 subjects that discontinued the study prior to the 24-month visit. The reason for discontinuation was due to death, retransplantation, and lost to follow-up. There were 5 deaths (3%), 2 retransplantations (1.2%), and 1 subject was lost to follow-up (0.6%).
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| Final Safety Findings |
The safety endpoint of this study is the 6-months liver graft survival post-transplant. This endpoint compares OCS Liver recipients to a pre-specified PG of 85.5%. The 6-month liver graft survival was 162 out of 164 (98.8%).
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| Final Effect Findings |
The primary endpoint was 1-year patient survival with the originally transplanted liver (patient and graft survival) post-liver transplant. This endpoint compares OCS Liver recipients to the pre-specified performance goal (PG) of 83.5%. The endpoint was met as patient and graft survival was 161 out of 166 (97%).
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| Study Strengths & Weaknesses |
All primary endpoints were successfully achieved. Safety profile remains acceptable with low complication rates. Device performance demonstrates continued effectiveness in clinical practice.
Longer-term follow-up may be beneficial to capture late biliary complications. Additional data on higher-risk donor populations (macrosteatosis >15%) may be valuable. Continued monitoring of device performance and clinical outcomes in routine practice would be beneficial.
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| Recommendations for Labeling Changes |
The labeling was previously updated following the 1-year Registry follow-up. The OCS Liver system labeling should be updated with the 2-year Registry follow-up data.
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