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NCT04496479 · ClinicalTrials.gov registry record · Phase 2
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
A Phase 2 study of End Stage Liver DIsease, sponsored by LyGenesis.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT04496479: Recruiting Phase 2 study of End Stage Liver DIsease, sponsored by LyGenesis.
NCT04496479 is a Phase 2 study of End Stage Liver DIsease that is actively recruiting participants, run by LyGenesis. The registered enrollment target is 12 participants, below the 491-participant average among 16 other End Stage Liver DIsease trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496479, a Phase 2 study of End Stage Liver DIsease, is actively recruiting participants, sponsored by LyGenesis.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
Primary Outcome
The primary objective of the dose escalation is to confirm the optimal dose of transplanted hepatocytes to safely achieve adequate allogeneic hepatocyte (AH) engraftment
Conditions Studied
Interventions
- BIOLOGICAL LYG-LIV0001
Study Locations (2)
Massachusetts
- Tufts Medical Center - Boston
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
What NCT04496479 shows while recruiting
NCT04496479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 491-participant average among 16 other End Stage Liver DIsease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with End Stage Liver DIsease appearing as the primary indexed condition, and to 1 intervention - of which LYG-LIV0001 is the first listed.
NCT04496479 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT04496479 about?
NCT04496479 is a clinical study titled "Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes". This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
What is the current status of trial NCT04496479?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-03-11. Estimated completion is 2027-12-30.
What conditions does trial NCT04496479 study?
This clinical trial studies the following conditions: End Stage Liver DIsease.
What interventions are being tested in trial NCT04496479?
The interventions under investigation include: LYG-LIV0001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04496479?
This trial is sponsored by LyGenesis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04496479 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04496479's enrollment target sits among peer trials
12 15th of 16 higher than 1 of 16 other End Stage Liver DIsease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Liver DIsease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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