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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PROTECT Continuation PAS


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General
Study Status Progress Adequate
Application Number P200031 / PAS001
Date Current Protocol Accepted  
Study Name PROTECT Continuation PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a continued follow-up of the OCS Liver PROTECT trial (premarket) cohort, designed to evaluate longer-term outcomes after liver transplantation in the OCS and control (cold storage) arms.
Study Population Description Patients who were randomized to OCS or control arms and transplanted in the PROTECT trial
Sample Size 300 patients who were randomized to OCS or control arms and transplanted in the PROTECT trial
Data Collection Main effectiveness endpoint: Liver graft survival at 24 months post-transplant

Other endpoint: patient survival at 24 months post-transplant
Follow-up Visits and Length of Follow-up 2 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 300
Actual Number of Sites Enrolled 20
Patient Follow-up Rate 93.6%
Final Safety Findings N/A
Final Effect Findings The Kaplan-Meier Analysis of Liver Graft Survival rates are 97% in both OCS and SOC arms for mITT & PP analysis groups with a log rank p-value of 0.96.
The Kaplan-Meier Analysis of Recipient Survival rates are 93% (OCS) and 92%(SOC) for both the mITT & PP analysis groups with a log rank p-value of 0.88.
Study Strengths & Weaknesses A strength of this study is that longer term follow-up data is very complete. A weakness of this study is that the 300 liver transplant recipients were enrolled at 20 sites however, 70% of the liver transplant recipients were enrolled at four of the clinical sites, therefore, the results of these four sites are driving the results of the overall PAS and thus the results of this PAS may not be generalizable to the liver transplant population at large.
Recommendations for Labeling Changes Yes


PROTECT Continuation PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 02/28/2022 01/27/2022 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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