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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468403
The ClinicalTrials.gov registry entry for NCT00468403 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00468403 reports 0 study locations.
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.
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