Liver TransplantationNCT04862156
WP02 Continued Access Study
A study testing Normothermic Machine Perfusion (NMP) in people with Liver Transplantation, run by OrganOx Ltd. at 7 sites in United States.
Trial summary
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Normothermic Machine Perfusion (NMP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Oct 2021to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements
Who cannot join
- Subject requiring all of the following at the time of transplantation:
- Oxygen therapy via a ventilator/respirator
- Inotropic support
- Renal replacement therapy
- Subject has acute/fulminant liver failure (UNOS status 1A)
- Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
- Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Duke University
Durham, North Carolina, 27710
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Loyola University Chicago
Maywood, Illinois, 60153
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University
St Louis, Missouri, 63110
About this study
Official title: Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
- Conditions
- Liver Transplantation
- Being tested
- Normothermic Machine Perfusion (NMP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic Machine Perfusion (NMP)Device
Also called OrganOx metra device
Storage and transportation of the donated liver using the OrganOx metra device.
| Study group | Role | What they receive |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | Experimental | 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. Receives: Device: Normothermic Machine Perfusion (NMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Allograft Dysfunction (EAD)
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start10 Oct 2021
- Primary completion31 Jul 2022
- Study completion7 Jul 2023
Why it stopped: FDA agreed that WP02 CAP could be stopped. The OrganOx metra device was approved on December 9, 2021. The 105 planned CAP patients will be included in the Post-Approval study (NCT05526326).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrganOx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862156
- Sponsor's protocol ID
- WP02
- Status last verified
- Jan 2024
- First submitted
- 21 Apr 2021
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
- ClinicalTrials.gov ID
- NCT04862156
- Acronym / sponsor ID
- WP02
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA agreed that WP02 CAP could be stopped. The OrganOx metra device was approved on December 9, 2021. The 105 planned CAP patients will be included in the Post-Approval study (NCT05526326).
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OrganOx Ltd.Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements
Key exclusion criteria (8 listed)
- Subject requiring all of the following at the time of transplantation:
- Subject has acute/fulminant liver failure (UNOS status 1A)
- Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
- Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic Machine Perfusion (NMP)Also: OrganOx metra deviceStorage and transportation of the donated liver using the OrganOx metra device. | Device | Normothermic Machine Perfusion (NMP) |
Primary outcome
Incidence of Early Allograft Dysfunction (EAD)
Time frame: 7 days
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Liver Transplantation
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Not yet recruiting
In-situ vs Ex-situ Liver Preservation
Liver Disease (Alcoholic or Not), Transplantation
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Sexual Dysfunction in Cirrhosis
Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation
RecruitingObservational study
Immune Biomarkers for Predicting Complications After Liver Transplantation
Liver Transplantation (LT), Immuno-suppression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic Machine Perfusion (NMP) in people with Liver Transplantation, run by OrganOx Ltd. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early Allograft Dysfunction (EAD) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.