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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200035 / PAS001 |
| Date Original Protocol Accepted |
12/09/2021
|
| Date Current Protocol Accepted |
04/12/2022
|
| Study Name |
WP01 Long-Term Follow-up PAS
|
| Device Name |
OrganOx metra System
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a continued follow-up of patients from the premarket WP01 clinical trial. Outcomes will be evaluated using data from the United Network of Organ Sharing (UNOS) database.
|
| Study Population |
The subjects of this study will be all the subjects receiving transplants in the WP01 IDE study where UNOS IDs were provided by the site and where subjects have consented to have their information sent to UNOS.
|
| Sample Size |
Up to 136 of 136 NMP transplants performed and up to 129 of 130 SCS transplants performed (final sample size pending evaluation of the number of patients that have consented to have their information sent to UNOS).
|
| Key Study Endpoints |
Primary objectives:
To assess graft and subject survival in identified subjects
To assess evidence of biliary complications in identified subjects
Secondary objectives:
To report post-transplant malignancy in identified subjects
To report viral detection in identified subjects
|
| Follow-up Visits and Length of Follow-up |
Data will be collected on subjects through 36 months post-transplant procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
265 (133 NMP and 132 SCS)
|
| Actual Number of Sites Enrolled |
Not applicable as patients’ data was provided by UNOS
|
| Patient Follow-up Rate |
Crude Follow-up Rates: 81% NMP and 80% SCS
|
| Final Safety Findings |
• Causes of subject death were related to malignancies in 6 of the deaths and were presented between 476 and 901 days after transplant. Three cases in the NMP and 3 cases in the SCS arms were reported.
• The bilirubin levels were acceptable because they ranged between 0.240 to 3.500 mg/dL thus not reaching critical values.
• There was one positive result for HBV Core Antibody 381 days post-transplant. This subject was not reported as experiencing graft failure or death in the data provided. All other reported results for post-transplant malignancy and viral detection were negative, not done, or unknown.
|
| Final Effect Findings |
• No graft failures reported in either arm between 12 and 24 months.
• Four (4) graft failures reported in the NMP arm 3 graft failure reported in the SCS arm from 24 to 36 months
• Kaplan Meier Estimates of Graft Survival – Transplanted and Consented to UNOS Data Collection (As Treated) showed comparable results
between arms at 36-month follow-up (96.9% NMP and 96.8% SCS arms).
• The Kaplan-Meier Estimates of Subject Survival showed higher events free rates in the SCS arm at 36-month follow-up (88.2% NMP and 90.9% SCS arms).
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| Study Strengths & Weaknesses |
Strengths: Randomization, Kaplan-Meier Estimates of Subject Survival and Graft Survival show comparable results between the two arms of the study.
Weaknesses: Although the results indicate no concerns related to safety or effectiveness, the sample size was not large enough to detect enough events to evaluate conclusively if there are safety and effectiveness differences between NMP and SCS.
|
| Recommendations for Labeling Changes |
The study elements and results need to be included in the labeling.
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