drugset / Trial / NCT00672204
Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes
Phase 1/2
Terminated
23 enrolled
University of Minnesota
Juvenile Diabetes Research Foundation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2010-12
- Completion
- 2012-08
Outcome
Outcome not reported
Stopped: “Raptiva was withdrawn from the market”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raptiva | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |
| Subject | Sirolimus | Small molecule | 0.05 mg/kg | Oral |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2 mg/kg | Intravenous |