Not provided
Not provided
Not provided
Not provided
Not provided
Business decision
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Herold Regimen | Experimental | 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. |
|
| Double-blind 33.3% Herold Regimen | Experimental | 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. |
|
| Double-blind Curtailed Herold Regimen | Experimental | 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. |
|
| Double-blind Placebo | Placebo Comparator | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples for safety | Diagnostic Test | serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest. | Duration of study participation up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | Month 6 | |
| Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Open-label Herold Regimen | Experimental | 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. |
|
| Patient reported outcome questionnaires | Behavioral | EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. |
|
| Analysis of T-cell subsets | Diagnostic Test | 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 |
|
| Month 12 |
| Proportion of Subjects With HbA1c <6.5% | Month 6 |
| Mean HbA1c at 6 Months | 6 months |
| Mean HbA1c at 12 Months | Month 12 |
| C-peptide Area Under the Curve (AUC) at 6 Months | This outcome measure summarizes the mean and standard deviation of the observed value. | Month 6 |
| C-peptide AUC at 12 Months | This outcome measure summarizes the mean and standard deviation of the observed value. | Month 12 |
| Total Daily Insulin Usage at 6 Months | Month 6 |
| Total Daily Insulin Usage at 12 Months | Month 12 |
| Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D) | The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life. | Month 6 |
| Mean Values for Participant-reported Outcomes on the EQ-5D | The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life. | Month 12 |
| Pediatric Quality of Life Questionnaire Total Score | The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed. | Month 6 |
| Pediatric Quality of Life Questionnaire Total Score | The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed. | Month 12 |
| Percentage of Cells by Immunophenotype | Month 6 |
| Human Anti-human Antibody (HAHA) Levels | Patients with HAHA levels > 0. | Month 6 and 12 |
| FG001 | Double-blind Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| FG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| FG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| FG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| Completed 6 Months |
|
| Completed 12 Months |
|
| Completed 18 Months |
|
| Completed 21 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| BG001 | Double-blind Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| BG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| BG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| BG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest. | Posted | Count of Participants | Participants | Duration of study participation up to 15 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Count of Participants | Participants | Month 6 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Count of Participants | Participants | Month 12 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With HbA1c <6.5% | Posted | Count of Participants | Participants | Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean HbA1c at 6 Months | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 6 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean HbA1c at 12 Months | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Month 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | C-peptide Area Under the Curve (AUC) at 6 Months | This outcome measure summarizes the mean and standard deviation of the observed value. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | min*nmol/L | Month 6 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | C-peptide AUC at 12 Months | This outcome measure summarizes the mean and standard deviation of the observed value. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | min*nmol/L | Month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Total Daily Insulin Usage at 6 Months | Posted | Mean | Standard Deviation | units/kg/day | Month 6 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Daily Insulin Usage at 12 Months | Posted | Mean | Standard Deviation | units/kg/day | Month 12 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D) | The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Values for Participant-reported Outcomes on the EQ-5D | The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life. | Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | units on a scale | Month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Pediatric Quality of Life Questionnaire Total Score | The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed. | Pediatric patients who completed the questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Pediatric Quality of Life Questionnaire Total Score | The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed. | Pediatric patients completing PedQL questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis. | Posted | Mean | Standard Deviation | units on a scale | Month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Cells by Immunophenotype | Posted | Mean | Standard Deviation | Percent | Month 6 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Human Anti-human Antibody (HAHA) Levels | Patients with HAHA levels > 0. | Posted | Count of Participants | Participants | Month 6 and 12 |
|
Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 | 0 | 32 | 1 | 32 | 8 | 32 |
| EG001 | Double-blind Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 | 1 | 73 | 5 | 73 | 2 | 73 |
| EG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 | 0 | 38 | 3 | 38 | 1 | 38 |
| EG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 | 0 | 38 | 4 | 38 | 10 | 38 |
| EG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 | 0 | 38 | 0 | 38 | 4 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MEddra | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemic seizure | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Caustic injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Epstein-Barr virus antibody positive | Investigations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
No formal inferential analyses were conducted due to limited number of participants. Data are summarized as mean change from baseline, both from Protégé and Extension baselines, for C-peptide AUC, HbA1c, insulin, and fasting C-peptide. Only existing data are summarized, no last observation carried forward imputation was performed. Patient reported outcomes were collected and summarized as mean change from baseline. However, only change from baseline from Extension could be summarized.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Rowland | Provention Bio, Inc | 443-987-0797 | SRowland@proventionbio.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| India |
|
| Romania |
|
| Ukraine |
|
| Israel |
|
| Spain |
|
| Estonia |
|
| Latvia |
|
| Poland |
|
| Sweden |
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| Double-blind Herold Regimen |
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| Double-blind Herold Regimen |
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG002 | Double-blind 33.3% Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|
| OG002 |
| Double-blind 33.3% Herold Regimen |
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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG003 | Double-blind Curtailed Herold Regimen | 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. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
| OG004 | Double-blind Placebo | Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information. 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 |
|
|