Trial Outcomes & Findings for WP02 Continued Access Study (NCT NCT04862156)
NCT ID: NCT04862156
Last Updated: 2025-04-15
Results Overview
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
7 days
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Normothermic Machine Perfusion (NMP)
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.
Normothermic Machine Perfusion (NMP): Storage and transportation of the donated liver using the OrganOx metra device.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
WP02 Continued Access Study
Baseline characteristics by cohort
| Measure |
Normothermic Machine Perfusion (NMP)
n=19 Participants
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.
Normothermic Machine Perfusion (NMP): Storage and transportation of the donated liver using the OrganOx metra device.
|
|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
BMI
|
31.8 Kg/m^2
STANDARD_DEVIATION 20.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysSeverity of immediate graft injury as measured by early allograft dysfunction (EAD).
Outcome measures
| Measure |
Normothermic Machine Perfusion (NMP)
n=19 Participants
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.
Normothermic Machine Perfusion (NMP): Storage and transportation of the donated liver using the OrganOx metra device.
|
|---|---|
|
Incidence of Early Allograft Dysfunction (EAD)
|
9 Participants
|
Adverse Events
Normothermic Machine Perfusion (NMP)
Serious events: 19 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Normothermic Machine Perfusion (NMP)
n=19 participants at risk
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.
Normothermic Machine Perfusion (NMP): Storage and transportation of the donated liver using the OrganOx metra device.
|
|---|---|
|
Infections and infestations
Infection
|
15.8%
3/19 • 1 year
|
|
Hepatobiliary disorders
Hepatic
|
31.6%
6/19 • 1 year
|
|
Immune system disorders
Autoimmune
|
5.3%
1/19 • 1 year
|
|
Cardiac disorders
Cardiovacular
|
21.1%
4/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
5.3%
1/19 • 1 year
|
|
Renal and urinary disorders
Genitourinary
|
31.6%
6/19 • 1 year
|
|
Surgical and medical procedures
Surgical Bleeding
|
5.3%
1/19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
21.1%
4/19 • 1 year
|
|
Blood and lymphatic system disorders
Hematology
|
5.3%
1/19 • 1 year
|
|
Psychiatric disorders
Neurology/Psychiatry
|
15.8%
3/19 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place