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

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MacroGenics

Status

Terminated

Conditions

Type 1 Diabetes Mellitus

Treatments

Diagnostic Test: Blood samples for safety
Diagnostic Test: Analysis of T-cell subsets
Behavioral: Patient reported outcome questionnaires

Study type

Interventional

Funder types

Industry

Identifiers

NCT00870818
CP-MGA031-02

Details and patient eligibility

About

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).

Full 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.

Enrollment

219 patients

Sex

All

Ages

10 to 37 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
  2. Provide written informed consent.

Exclusion criteria

None

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

219 participants in 5 patient groups, including a placebo group

Double-blind Herold Regimen
Experimental group
Description:
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Treatment:
Behavioral: Patient reported outcome questionnaires
Diagnostic Test: Analysis of T-cell subsets
Diagnostic Test: Blood samples for safety
Double-blind 33.3% Herold Regimen
Experimental group
Description:
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Treatment:
Behavioral: Patient reported outcome questionnaires
Diagnostic Test: Analysis of T-cell subsets
Diagnostic Test: Blood samples for safety
Double-blind Curtailed Herold Regimen
Experimental group
Description:
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Treatment:
Behavioral: Patient reported outcome questionnaires
Diagnostic Test: Analysis of T-cell subsets
Diagnostic Test: Blood samples for safety
Double-blind Placebo
Placebo Comparator group
Description:
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Treatment:
Behavioral: Patient reported outcome questionnaires
Diagnostic Test: Analysis of T-cell subsets
Diagnostic Test: Blood samples for safety
Open-label Herold Regimen
Experimental group
Description:
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Treatment:
Behavioral: Patient reported outcome questionnaires
Diagnostic Test: Analysis of T-cell subsets
Diagnostic Test: Blood samples for safety

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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