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NCT00468403 · ClinicalTrials.gov registry record · Phase 2
LEA29Y (Belatacept) Emory Edmonton Protocol
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00468403: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00468403 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00468403, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation using a steroid-free, calcineurin-inhibitor-free belatacept based immunosuppressive medication, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- BIOLOGICAL Basiliximab
- BIOLOGICAL Belatacept
- BIOLOGICAL Allogeneic Pancreatic Islet Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00468403 record still lists
NCT00468403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00468403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00468403 about?
NCT00468403 is a clinical study titled "LEA29Y (Belatacept) Emory Edmonton Protocol". Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation using a steroid-free, calcineurin-inhibitor-free belatac...
What is the current status of trial NCT00468403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00468403?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Basiliximab (BIOLOGICAL), Belatacept (BIOLOGICAL), Allogeneic Pancreatic Islet Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00468403?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00468403's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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