drugset / Trial / NCT00008801
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
Phase 1/2
Unknown
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.
Timeline
- Start
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- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teplizumab | Monoclonal antibody | — | — |