Incidence of Early Allograft Dysfunction (EAD)
Primary
· 7 days
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
| Group | Value | 95% CI |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | 9 |
Last reviewed · How we verify
NCT04862156
WP02 Continued Access Study
Terminated
NA
Results posted
Last updated 15 April 2025
What this trial tests
NA trial testing Normothermic Machine Perfusion (NMP) in Liver Transplantation in 19 participants. Terminated before completion.
Timeline
10 October 2021
Primary endpoint
31 July 2022
31 July 2022
7 July 2023
Quick facts
| Lead sponsor | OrganOx Ltd. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 10 October 2021 |
| Primary completion | 31 July 2022 |
| Estimated completion | 7 July 2023 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Normothermic Machine Perfusion (NMP)
Conditions studied
- Liver Transplantation — all drugs for Liver Transplantation →
Sponsor
OrganOx Ltd.
Who can join
18 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Normothermic Machine Perfusion (NMP)
Serious: 19/19 (100%)
Deaths: 2/19
Serious adverse events (10 terms)
| Reaction | System | Normothermic Machine Perfu… |
|---|---|---|
| Hepatic | Hepatobiliary disorders | — |
| Genitourinary | Renal and urinary disorders | — |
| Cardiovacular | Cardiac disorders | — |
| Respiratory | Respiratory, thoracic and mediastinal disorders | — |
| Infection | Infections and infestations | — |
| Neurology/Psychiatry | Psychiatric disorders | — |
| Autoimmune | Immune system disorders | — |
| Dermatologic | Skin and subcutaneous tissue disorders | — |
| Surgical Bleeding | Surgical and medical procedures | — |
| Hematology | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Hepatic, Genitourinary, Cardiovacular, Respiratory, Infection, Neurology/Psychiatry, Autoimmune, Dermatologic.
Data from ClinicalTrials.gov NCT04862156 adverse events section.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Current Role and Future Applications of Machine Perfusion in Liver Transplantation.
Staubli SM, Ceresa CDL, Pollok JM. · · 2023 · cited 9× · PMID 37237663 · DOI 10.3390/bioengineering10050593
Verify or expand the search:
- PubMed search for NCT04862156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Normothermic Machine Perfusion (NMP)
Trials testing the same drug.
- NCT02775162 — WP01 - Normothermic Liver Preservation · NA · completed
Other recruiting trials for Liver Transplantation
Currently open trials in the same condition.
- NCT07157631 — Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial · NA · recruiting
- NCT07123740 — Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors · NA · recruiting
- NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
- NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
- NCT06874296 — Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time · NA · recruiting
Other OrganOx Ltd. trials
Trials by the same sponsor.
- NCT05526326 — OrganOx Metra® New Enrollment PAS · completed
- NCT02775162 — WP01 - Normothermic Liver Preservation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04862156 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by OrganOx Ltd.
- Last refreshed: 15 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04862156.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing