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

NCT00870818 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2023-08-09

Study results available
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Summary

The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870818 on ClinicalTrials.gov