NCT00870818 - Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01) | Biotech Hunter

Enrollment

219

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

May 31, 2011

Conditions

Type 1 Diabetes Mellitus

Interventions

DIAGNOSTIC_TEST

Blood samples for safety

serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies

BEHAVIORAL

Patient reported outcome questionnaires

EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.

DIAGNOSTIC_TEST

Analysis of T-cell subsets

CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets

Trial Locations (1)

30309

Atlanta Diabetes Associates, Atlanta