Trials / Terminated
TerminatedNCT00870818
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 219 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 10 Years – 37 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01. The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-02-01
- Completion
- 2011-05-01
- First posted
- 2009-03-27
- Last updated
- 2023-08-09
- Results posted
- 2023-08-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00870818. Inclusion in this directory is not an endorsement.