CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Efalizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00276250
NCT00276250Phase 2Completed
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Development of Immunosuppression Regimens to Facilitate Single Donor Islet Transplantation Using Abatacept

Emory University·interventional·Posted Jan 13, 2006·Updated Jul 27, 2016

In Brief

A Phase 2 clinical trial evaluating Efalizumab, Abatacept, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 5 participants across 1 site.

Detailed Summary

Islet transplantation in type 1 diabetics with hypoglycemic unawareness using abatacept as a part of a novel calcineurin-inhibitor-sparing immunosuppressive regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2006
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 20.5 years ago

Interventions

Efalizumabdrug

Efalizumab was a medication approved for use in psoriasis which was being explored to determine efficacy with immunosuppression following organ transplantation. Efalizumab was administered subcutaneously on a weekly basis. Upon efalizumab being withdrawn from the US market, the protocol was amended to alter the immunosuppressive regimen to abatacept for the study participants.

Abataceptdrug

Abatacept is drug used to treat autoimmune diseases. Abatacept is administered intravenously, monthly, in weight-based doses and is given for as long as transplanted islets are functioning.

Belataceptdrug

Belatacept is a medication to provide extended graft survival while limiting the toxicity generated by standard immune suppressing regimens. Belatacept is administered intravenously. The protocol for this study was amended to substitute belatacept for abatacept for all newly enrolling participants (current participants remained on abatacept).