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NCT00672204 · ClinicalTrials.gov registry record · Phase 1
Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes
A Phase 1 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00672204: Clinical Trial Phase 1 study, sponsored by University of Minnesota.
NCT00672204 is a Phase 1 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00672204, a Phase 1 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection of islet transplants in type 1 diabetic recipients. Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market in April of 2009. Previously transplanted subjects have been transitioned to alternative immunosuppressives and no new subjects will be transplanted under this protocol.
Primary Outcome
Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met: * HbA1c \< 7.0% or a ≥2.5% decrease from baseline; * fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period); * 2-hour post-prandial capillary gl
Interventions
- DRUG Sirolimus
- DRUG anti-thymocyte globulin
- DRUG Raptiva
- BIOLOGICAL Allogeneic islets of Langerhans transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
Why NCT00672204 stopped before completion
NCT00672204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00672204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00672204 about?
NCT00672204 is a clinical study titled "Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes". The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection...
What is the current status of trial NCT00672204?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00672204?
The interventions under investigation include: Sirolimus (DRUG), anti-thymocyte globulin (DRUG), Raptiva (DRUG), Allogeneic islets of Langerhans transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00672204?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00672204's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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