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NCT04208919 · ClinicalTrials.gov registry record · Phase 1
Delayed Infusion of DCreg in Living Donor Liver Transplantation
A Phase 1 study of Living Donor Liver Transplantation, sponsored by Angus W. Thomson PhD DSc.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04208919 is a Phase 1 study of Living Donor Liver Transplantation that is active but no longer recruiting, run by Angus W. Thomson PhD DSc. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04208919, a Phase 1 study of Living Donor Liver Transplantation, is active but no longer recruiting, sponsored by Angus W. Thomson PhD DSc.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients who are between 1 and 3 years after transplantation and meet specific criteria (no positive crossmatch, no clinically treated rejection within 2 years preceding enrollment, permissive liver function tests (LFTs) within 30 days preceding enrollment, no prior liver biopsy showing significant fibrosis or ductopenia\*) will be enrolled and will undergo a protocol liver biopsy unless they have had a permissive liver biopsy\*\* within 90 days of anticipated immunosuppression weaning. Those patients with permissive liver biopsy\*\* will then receive a single infusion of donor-derived DCreg and will remain on their current standard of care (SOC) immunosuppression. One week after DCreg infusion, immunosuppression weaning will be initiated. Recipients will be slowly weaned off immunosuppression. Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression. They will undergo a liver biopsy at 1 yr and 3 yrs after immunosuppression withdrawal. Participants who are removed from the study protocol at any time will return to standard of care but will continue to be followed by the study team and will undergo a liver biopsy at the end of the study. \* Permissive LFTs are defined as ALT, AST and total bilirubin \< 2.5 times the upper limit of normal. \*\*A permissive biopsy is based on 2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology (the criteria detailed in Table 8, Demetris et al. 2016).
Conditions Studied
Interventions
- BIOLOGICAL Donor-derived DCreg
Study Locations (1)
Pennsylvania
- UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04208919
The ClinicalTrials.gov registry entry for NCT04208919 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angus W. Thomson PhD DSc, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Living Donor Liver Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Donor-derived DCreg is the first listed.
NCT04208919 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04208919 about?
NCT04208919 is a clinical study titled "Delayed Infusion of DCreg in Living Donor Liver Transplantation". Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients who are between 1 and 3 years after transplantation and meet specific criteria (no positive crossmatch, no clinically tre...
What is the current status of trial NCT04208919?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-12-18. Estimated completion is 2026-06.
What conditions does trial NCT04208919 study?
This clinical trial studies the following conditions: Living Donor Liver Transplantation.
What interventions are being tested in trial NCT04208919?
The interventions under investigation include: Donor-derived DCreg (BIOLOGICAL).
Who is sponsoring clinical trial NCT04208919?
This trial is sponsored by Angus W. Thomson PhD DSc, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04208919 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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