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Study of Antithymocyte Globulin for Treatment of New-onset T1DM (START)

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ClinicalTrials.gov Identifier: NCT00515099
Recruitment Status : Terminated (Slow accrual)
First Posted : August 13, 2007
Results First Posted : April 21, 2014
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition New-onset Type 1 Diabetes Mellitus
Interventions Drug: Antithymocyte globulin
Drug: Placebo
Enrollment 58
Recruitment Details Subjects were recruited during an approximate 40-month accrual period. Initially 66 subjects were planned, however enrollment closed early at 58 subjects on June 30, 2011 secondary to slow accrual (planned 30-month accrual period).
Pre-assignment Details Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment.
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg. This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Period Title: Overall Study
Started 38 20
Completed 35 16
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             0             4
Withdrawal by Subject             2             0
IRB Recommendation             1             0
Arm/Group Title Antithymocyte Globulin Placebo Total
Hide Arm/Group Description This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg. This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg. Total of all reporting groups
Overall Number of Baseline Participants 38 20 58
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 20 participants 58 participants
<=18 years
19
  50.0%
10
  50.0%
29
  50.0%
Between 18 and 65 years
19
  50.0%
10
  50.0%
29
  50.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 20 participants 58 participants
19.4  (6.6) 20.5  (7.1) 19.8  (6.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 20 participants 58 participants
12 -15 Years 13 6 19
16 - 21 Years 13 6 19
22 - 35 Years 12 8 20
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 20 participants 58 participants
Female
14
  36.8%
9
  45.0%
23
  39.7%
Male
24
  63.2%
11
  55.0%
35
  60.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 20 participants 58 participants
38 20 58
1.Primary Outcome
Title 2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Hide Description C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.
Time Frame Baseline (Pre-treatment initiation), Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.86  (0.37) 0.93  (0.50)
Month 12 0.66  (0.37) 0.69  (0.52)
Change from Baseline (Pre-treatment initiation) -0.20  (0.29) -0.24  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title 4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Hide Description C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy endpoint.
Time Frame Baseline (Pre-treatment initiation), Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.86  (0.30) 0.90  (0.37)
Month 12 0.67  (0.38) 0.63  (0.39)
Change from Baseline (Pre-treatment initiation) -0.19  (0.30) -0.27  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Insulin Use in Units Per Kilogram Body Weight Per Day
Hide Description The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.
Time Frame Baseline (Pre-treatment), Months 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Mean (Standard Deviation)
Unit of Measure: units/day/kg
Baseline (Pre-treatment initiation) 0.34  (0.22) 0.42  (0.24)
Month 12 0.40  (0.24) 0.49  (0.26)
Change from Baseline to Month 12 0.07  (0.20) 0.08  (0.20)
Month 24 0.54  (0.31) 0.47  (0.21)
Change from Baseline to Month 24 0.19  (0.23) 0.06  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups for change from baseline (pre-treatment initiation) to Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups for change from baseline (pre-treatment initiation) to Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Are Exogenous-Insulin-Free
Hide Description The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.
Time Frame Baseline (Pre-treatment), Months 12 , 18, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Measure Type: Number
Unit of Measure: participants
Baseline (Pre-treatment initiation) 1 0
Month 12 1 0
Month 18 1 0
Month 24 1 0
5.Secondary Outcome
Title Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation
Hide Description Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.
Time Frame Baseline (Pre-treatment), Months 12 , and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Measure Type: Number
Unit of Measure: participants
Participants with Hypoglycemic Events Up to Mo. 12 23 12
Participants with Hypoglycemic Events Up to Mo. 24 30 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups up to Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.099
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups up to Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title 2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Hide Description C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) and 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the CDER at the FDA as a valid efficacy endpoint.
Time Frame Baseline (Pre-treatment), Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.86  (0.37) 0.93  (0.50)
2-hour AUC Month 24 0.58  (0.43) 0.61  (0.67)
Change from 2-hr MMTT Baseline -0.27  (0.31) -0.32  (0.32)
4-hour AUC Month 24 0.56  (0.36) 0.59  (0.63)
Change from 4-hr MMTT Baseline -0.26  (0.28) -0.31  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments 2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments 4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Hemoglobin A1c
Hide Description Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c of <\=5.6% is considered normal. HbA1c of 6.5% or higher is typical for individuals with Type 1 Diabetes mellitus (T1DM).
Time Frame Baseline (Pre-treatment), Months 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description:
This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Overall Number of Participants Analyzed 38 20
Mean (Standard Deviation)
Unit of Measure: Percentage (%)
Baseline (Pre-treatment initiation) 6.7  (1.3) 6.8  (1.2)
Month 12 6.9  (1.6) 7.7  (1.8)
Change from Baseline to Month 12 0.1  (1.8) 1.0  (1.5)
Month 24 7.5  (1.5) 8.2  (2.4)
Change from Baseline to Month 24 0.6  (1.8) 1.4  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups for change from Baseline to Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithymocyte Globulin, Placebo
Comments Comparison of groups for change from Baseline to Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
Time Frame From baseline (e.g., when informed consent signed) through study completion. The first participant enrolled in September 2007 and the last participant last visit for the study occurred in July 2013.
Adverse Event Reporting Description

Adverse Events (AEs) could be discovered through any of these methods:

  • Observing the participant.
  • Questioning the participant in an objective manner.
  • Receiving an unsolicited complaint from the participant.
 
Arm/Group Title Antithymocyte Globulin Placebo
Hide Arm/Group Description This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg. This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
All-Cause Mortality
Antithymocyte Globulin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Antithymocyte Globulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/38 (23.68%)      4/20 (20.00%)    
Immune system disorders     
Cytokine release syndrome  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Serum sickness  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Gastroenteritis viral  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Salmonellosis  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Viral infection  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Injury, poisoning and procedural complications     
Comminuted fracture  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Investigations     
CD4 lymphocytes decreased  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Diabetic ketoacidosis  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Hyperglycaemia  1  2/38 (5.26%)  4 1/20 (5.00%)  1
Hypoglycaemia  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Ketosis  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Nervous system disorders     
Syncope  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Psychiatric disorders     
Affective disorder  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Bipolar disorder  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Depression  1  1/38 (2.63%)  4 1/20 (5.00%)  1
Major depression  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Mood altered  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Substance abuse  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Suicidal ideation  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
Exfoliative rash  1  1/38 (2.63%)  2 0/20 (0.00%)  0
Vascular disorders     
Axillary vein thrombosis  1  1/38 (2.63%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antithymocyte Globulin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/38 (100.00%)      20/20 (100.00%)    
Blood and lymphatic system disorders     
Leukopenia  1  14/38 (36.84%)  20 0/20 (0.00%)  0
Lymphadenopathy  1  1/38 (2.63%)  1 2/20 (10.00%)  2
Lymphopenia  1  38/38 (100.00%)  48 0/20 (0.00%)  0
Neutropenia  1  9/38 (23.68%)  10 2/20 (10.00%)  4
Thrombocytopenia  1  5/38 (13.16%)  5 0/20 (0.00%)  0
Cardiac disorders     
Bradycardia  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Ear and labyrinth disorders     
Ear pain  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Middle ear effusion  1  0/38 (0.00%)  0 1/20 (5.00%)  2
Eye disorders     
Eye irritation  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Ocular hyperaemia  1  3/38 (7.89%)  3 0/20 (0.00%)  0
Visual impairment  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/38 (7.89%)  3 1/20 (5.00%)  1
Abdominal pain lower  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Abdominal pain upper  1  3/38 (7.89%)  3 1/20 (5.00%)  1
Constipation  1  5/38 (13.16%)  6 0/20 (0.00%)  0
Diarrhoea  1  5/38 (13.16%)  5 3/20 (15.00%)  3
Dyspepsia  1  2/38 (5.26%)  2 3/20 (15.00%)  3
Gastritis  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Gastrooesophageal reflux disease  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Nausea  1  7/38 (18.42%)  8 5/20 (25.00%)  7
Oral disorder  1  2/38 (5.26%)  4 0/20 (0.00%)  0
Toothache  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Vomiting  1  3/38 (7.89%)  4 3/20 (15.00%)  3
General disorders     
Catheter site pain  1  5/38 (13.16%)  5 1/20 (5.00%)  1
Chest discomfort  1  3/38 (7.89%)  3 1/20 (5.00%)  1
Chest pain  1  2/38 (5.26%)  2 1/20 (5.00%)  1
Face oedema  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Fatigue  1  3/38 (7.89%)  4 4/20 (20.00%)  5
Influenza like illness  1  2/38 (5.26%)  2 3/20 (15.00%)  3
Infusion site pain  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Infusion site swelling  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Injection site discolouration  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Injection site hypertrophy  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Malaise  1  2/38 (5.26%)  2 1/20 (5.00%)  1
Pain  1  2/38 (5.26%)  2 1/20 (5.00%)  1
Pyrexia  1  6/38 (15.79%)  6 1/20 (5.00%)  1
Hepatobiliary disorders     
Hyperbilirubinaemia  1  3/38 (7.89%)  3 0/20 (0.00%)  0
Immune system disorders     
Cytokine release syndrome  1  36/38 (94.74%)  36 1/20 (5.00%)  1
Seasonal allergy  1  7/38 (18.42%)  8 2/20 (10.00%)  2
Serum sickness  1  36/38 (94.74%)  37 0/20 (0.00%)  0
Infections and infestations     
Bronchitis  1  4/38 (10.53%)  5 0/20 (0.00%)  0
Ear infection  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Eye infection  1  0/38 (0.00%)  0 1/20 (5.00%)  2
Gastroenteritis  1  2/38 (5.26%)  2 1/20 (5.00%)  1
Gingival infection  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Influenza  1  3/38 (7.89%)  3 0/20 (0.00%)  0
Nasopharyngitis  1  5/38 (13.16%)  5 1/20 (5.00%)  1
Oral herpes  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Otitis media  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Pharyngitis  1  2/38 (5.26%)  2 2/20 (10.00%)  2
Pharyngitis streptococcal  1  2/38 (5.26%)  3 2/20 (10.00%)  2
Pneumonia  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Sinusitis  1  5/38 (13.16%)  7 1/20 (5.00%)  1
Upper respiratory tract infection  1  16/38 (42.11%)  32 7/20 (35.00%)  16
Viral infection  1  5/38 (13.16%)  10 3/20 (15.00%)  3
Injury, poisoning and procedural complications     
Arthropod bite  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Contusion  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Excoriation  1  4/38 (10.53%)  5 0/20 (0.00%)  0
Fibula fracture  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Foot fracture  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Hand fracture  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Joint sprain  1  3/38 (7.89%)  3 0/20 (0.00%)  0
Sunburn  1  2/38 (5.26%)  3 1/20 (5.00%)  1
Investigations     
Alanine aminotransferase increased  1  2/38 (5.26%)  3 0/20 (0.00%)  0
Aspartate aminotransferase increased  1  2/38 (5.26%)  4 0/20 (0.00%)  0
CD4 lymphocytes decreased  1  37/38 (97.37%)  37 0/20 (0.00%)  0
Glycosylated haemoglobin increased  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Haptoglobin increased  1  2/38 (5.26%)  2 0/20 (0.00%)  0
T-lymphocyte count decreased  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Weight decreased  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders     
Hyperglycaemia  1  7/38 (18.42%)  8 1/20 (5.00%)  3
Hypoglycaemia  1  31/38 (81.58%)  493 16/20 (80.00%)  201
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/38 (10.53%)  4 3/20 (15.00%)  4
Back pain  1  4/38 (10.53%)  5 5/20 (25.00%)  6
Muscle spasms  1  2/38 (5.26%)  2 1/20 (5.00%)  1
Musculoskeletal pain  1  1/38 (2.63%)  1 3/20 (15.00%)  3
Myalgia  1  4/38 (10.53%)  4 2/20 (10.00%)  3
Pain in extremity  1  2/38 (5.26%)  3 2/20 (10.00%)  2
Rotator cuff syndrome  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Dizziness  1  4/38 (10.53%)  4 2/20 (10.00%)  2
Dysaesthesia  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Headache  1  18/38 (47.37%)  25 10/20 (50.00%)  15
Lethargy  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Migraine  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Somnolence  1  0/38 (0.00%)  0 2/20 (10.00%)  3
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Psychiatric disorders     
Affective disorder  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Agitation  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Anxiety  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Attention deficit/hyperactivity disorder  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Depression  1  3/38 (7.89%)  3 3/20 (15.00%)  3
Insomnia  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Restlessness  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  0/38 (0.00%)  0 2/20 (10.00%)  2
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Ovarian cyst  1  2/38 (5.26%)  3 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Bronchospasm  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Cough  1  8/38 (21.05%)  10 4/20 (20.00%)  5
Epistaxis  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Nasal congestion  1  3/38 (7.89%)  4 3/20 (15.00%)  4
Oropharyngeal pain  1  9/38 (23.68%)  13 5/20 (25.00%)  6
Pharyngeal erythema  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Productive cough  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Rhinitis allergic  1  2/38 (5.26%)  4 1/20 (5.00%)  1
Rhinorrhoea  1  1/38 (2.63%)  1 3/20 (15.00%)  3
Sinus congestion  1  4/38 (10.53%)  4 1/20 (5.00%)  1
Tonsillar hypertrophy  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
Acne  1  7/38 (18.42%)  8 1/20 (5.00%)  1
Blister  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Dermatitis contact  1  2/38 (5.26%)  2 3/20 (15.00%)  3
Eczema  1  1/38 (2.63%)  1 1/20 (5.00%)  1
Ingrowing nail  1  2/38 (5.26%)  2 0/20 (0.00%)  0
Lipoatrophy  1  0/38 (0.00%)  0 1/20 (5.00%)  2
Lipohypertrophy  1  0/38 (0.00%)  0 2/20 (10.00%)  4
Pruritus  1  4/38 (10.53%)  4 3/20 (15.00%)  4
Rash  1  7/38 (18.42%)  8 2/20 (10.00%)  3
Rash papular  1  3/38 (7.89%)  3 0/20 (0.00%)  0
Rash pruritic  1  1/38 (2.63%)  1 1/20 (5.00%)  5
Urticaria  1  2/38 (5.26%)  2 2/20 (10.00%)  2
Vascular disorders     
Flushing  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Hot flush  1  0/38 (0.00%)  0 1/20 (5.00%)  1
Hypotension  1  0/38 (0.00%)  0 3/20 (15.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Enrollment for this trial was closed at 58 participants and did not meet the planned sample size of 66 participants due to slow accrual.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00515099     History of Changes
Other Study ID Numbers: DAIT ITN028AI
First Submitted: August 10, 2007
First Posted: August 13, 2007
Results First Submitted: February 10, 2014
Results First Posted: April 21, 2014
Last Update Posted: May 11, 2017