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NCT03164265 · ClinicalTrials.gov registry record · Phase 1
DCreg in Living Donor Liver Transplantation
A Phase 1 study of Living Donor Liver Transplantation, sponsored by Angus W. Thomson PhD DSc.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03164265 is a Phase 1 study of Living Donor Liver Transplantation that has completed, run by Angus W. Thomson PhD DSc. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03164265, a Phase 1 study of Living Donor Liver Transplantation, has completed, sponsored by Angus W. Thomson PhD DSc.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 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 will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific criteria be weaned off Tac over 6 months . Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.
Conditions Studied
Interventions
- BIOLOGICAL Regulatory Donor-Derived Dendritic Cell infusion
Study Locations (1)
Pennsylvania
- UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-08-30 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03164265
The ClinicalTrials.gov registry entry for NCT03164265 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 Regulatory Donor-Derived Dendritic Cell infusion is the first listed.
NCT03164265 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03164265 about?
NCT03164265 is a clinical study titled "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 will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on...
What is the current status of trial NCT03164265?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-08-30. Estimated completion is 2024-07-15.
What conditions does trial NCT03164265 study?
This clinical trial studies the following conditions: Living Donor Liver Transplantation.
What interventions are being tested in trial NCT03164265?
The interventions under investigation include: Regulatory Donor-Derived Dendritic Cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03164265?
This trial is sponsored by Angus W. Thomson PhD DSc, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03164265 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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