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Islet Transplantation with Campath-1H and Infliximab Induction
NCT00175266Phase 2
Key facts
- Status
- Completed
- Countries
- 1
- Sponsor
- University of Alberta
- Modality
- Monoclonal Antibodies
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, open-label, single-arm trial of alemtuzumab and infliximab in type 1 diabetes mellitus (T1D), sponsored by University of Alberta. Primary endpoint: Safety of treatment regimen. Status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Islet Transplant with Induction
Campath-1H + Infliximab induction, Islet Transplant, Sirolimus + Tacrolimus maintenance
03
Who it enrols
Adult patients with Type 1 diabetes for >5 years, complicated by hypoglycemia unawareness, metabolic lability, or progressive complications, with negative C-peptide and adequate renal function.
04
Endpoints
Primary
Safety of treatment regimen
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