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Trial record 39 of 2400 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE)

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ClinicalTrials.gov Identifier: NCT00129259
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : September 16, 2013
Last Update Posted : May 22, 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: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Biological: Anti-CD3 mAb
Other: Diabetes Standard of Care Treatment
Dietary Supplement: Iron supplementation
Enrollment 83
Recruitment Details Seven centers randomized 83 subjects between September 2005 and March 2009. Seventy-seven subjects are in the intent-to-treat (ITT) population. Those not in the ITT population did not have a baseline visit and were not included in the participant flow portion of the results section.
Pre-assignment Details At a screening visit, subjects underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All subjects or guardians provided written informed consent at screening.
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Hide Arm/Group Description

Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.

Iron supplementation was initiated status post treatment randomization.

Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.

Iron supplementation was initiated status post treatment randomization.

Period Title: Overall Study
Started 52 [1] 25 [1]
Received All or Part of Cycle 1 52 0
Received All or Part of Cycle 2 40 0
Completed 49 22
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             2             1
Only available minimal phone assessments             0             1
[1]
Subjects not in the Intent-to-treat group did not have a baseline visit and are not included here
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment Total
Hide Arm/Group Description Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team. Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team. Total of all reporting groups
Overall Number of Baseline Participants 52 25 77
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 25 participants 77 participants
12.7  (4.9) 12.3  (4.1) 12.5  (4.6)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 25 participants 77 participants
8-12 34 15 49
13-17 14 9 23
18-30 4 1 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 25 participants 77 participants
Female
24
  46.2%
9
  36.0%
33
  42.9%
Male
28
  53.8%
16
  64.0%
44
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 25 participants 77 participants
52 25 77
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  pmol/mL
Number Analyzed 52 participants 25 participants 77 participants
0.72  (0.29) 0.67  (0.28) 0.70  (0.29)
[1]
Measure Description: C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT.
Hemoglobin A1c at Baseline (Pre-treatment)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage (%)
Number Analyzed 52 participants 25 participants 77 participants
7.4  (0.99) 7.7  (1.23) 7.5  (1.07)
[1]
Measure Description: Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).
Average Total Daily Insulin Dose Per Body Weight at Baseline (Pre-treatment)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units of Insulin/kilogram/day (U/kg/day)
Number Analyzed 52 participants 25 participants 77 participants
0.39  (0.26) 0.39  (0.17) 0.39  (0.23)
[1]
Measure Description: This measure is computed using the subject’s average amount of exogenous insulin taken per day for the 3 days prior to the visit. (Formula: Total daily insulin dose=total daily insulin requirement (in units of insulin) multiplied by total body weight in kilograms).
1.Primary Outcome
Title Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)
Hide Description C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario.
Time Frame Baseline (Pre-treatment), Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Hide Arm/Group Description:
Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Overall Number of Participants Analyzed 52 25
Least Squares Mean (95% Confidence Interval)
Unit of Measure: pmol/mL
-0.28
(-0.36 to -0.20)
-0.46
(-0.57 to -0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-CD3 mAb Plus Diabetes Standard of Care Treatment, Diabetes Standard of Care Treatment
Comments

Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.

Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).
2.Secondary Outcome
Title Change in HbA1c
Hide Description Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia.
Time Frame Baseline (Pre-treatment), Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Hide Arm/Group Description:
Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Overall Number of Participants Analyzed 48 21
Mean (Standard Deviation)
Unit of Measure: Percentage (%)
0.129  (2.032) 0.195  (1.683)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-CD3 mAb Plus Diabetes Standard of Care Treatment, Diabetes Standard of Care Treatment
Comments

Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.

Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusts for baseline HbA1c.
3.Secondary Outcome
Title Change in Average Total Insulin Dose Per Body Weight
Hide Description This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease.
Time Frame Baseline (Pre-treatment), Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Hide Arm/Group Description:
Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Overall Number of Participants Analyzed 46 22
Mean (Standard Deviation)
Unit of Measure: Units of Insulin/kilogram/day (U/kg/day)
0.23  (0.29) 0.35  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-CD3 mAb Plus Diabetes Standard of Care Treatment, Diabetes Standard of Care Treatment
Comments

Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.

Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusts for baseline daily insulin use per kg
Time Frame From the initiation of study treatment through month 24 visit (i.e., throughout the duration of the study)
Adverse Event Reporting Description This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
 
Arm/Group Title Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Hide Arm/Group Description Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team. Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
All-Cause Mortality
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/52 (19.23%)      1/25 (4.00%)    
Immune system disorders     
Cytokine release syndrome  1  2/52 (3.85%)  2 0/25 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Diarrhoea infectious  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Infection  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Injury, poisoning and procedural complications     
Skull fracture  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Splenic rupture  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Hypoglycaemia  1  2/52 (3.85%)  2 1/25 (4.00%)  1
Nervous system disorders     
Cerebral haemorrhage  1  1/52 (1.92%)  1 0/25 (0.00%)  0
Psychiatric disorders     
Hallucination  1  0/52 (0.00%)  0 1/25 (4.00%)  1
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%
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment Diabetes Standard of Care Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/52 (100.00%)      23/25 (92.00%)    
Blood and lymphatic system disorders     
Anaemia  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Leukopenia  1  12/52 (23.08%)  24 0/25 (0.00%)  0
Lymphadenopathy  1  4/52 (7.69%)  4 0/25 (0.00%)  0
Lymphopenia  1  22/52 (42.31%)  41 0/25 (0.00%)  0
Neutropenia  1  9/52 (17.31%)  15 0/25 (0.00%)  0
Thrombocytopenia  1  5/52 (9.62%)  5 0/25 (0.00%)  0
Endocrine disorders     
Goitre  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Hypothyroidism  1  0/52 (0.00%)  0 2/25 (8.00%)  2
Gastrointestinal disorders     
Abdominal pain  1  16/52 (30.77%)  20 0/25 (0.00%)  0
Abdominal pain upper  1  9/52 (17.31%)  12 6/25 (24.00%)  6
Constipation  1  5/52 (9.62%)  6 0/25 (0.00%)  0
Diarrhoea  1  4/52 (7.69%)  4 1/25 (4.00%)  1
Nausea  1  25/52 (48.08%)  43 5/25 (20.00%)  6
Vomiting  1  19/52 (36.54%)  34 3/25 (12.00%)  4
General disorders     
Catheter site rash  1  7/52 (13.46%)  7 0/25 (0.00%)  0
Chills  1  5/52 (9.62%)  5 1/25 (4.00%)  1
Fatigue  1  7/52 (13.46%)  9 1/25 (4.00%)  1
Infusion site pain  1  6/52 (11.54%)  6 1/25 (4.00%)  1
Malaise  1  3/52 (5.77%)  3 2/25 (8.00%)  2
Pyrexia  1  20/52 (38.46%)  27 5/25 (20.00%)  5
Hepatobiliary disorders     
Hyperbilirubinaemia  1  3/52 (5.77%)  4 1/25 (4.00%)  1
Immune system disorders     
Cytokine release syndrome  1  5/52 (9.62%)  6 0/25 (0.00%)  0
Seasonal allergy  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Infections and infestations     
Acne pustular  1  5/52 (9.62%)  6 3/25 (12.00%)  3
Bronchitis  1  3/52 (5.77%)  3 4/25 (16.00%)  4
Conjunctivitis infective  1  3/52 (5.77%)  4 1/25 (4.00%)  1
Diarrhoea infectious  1  6/52 (11.54%)  6 2/25 (8.00%)  2
Ear infection  1  4/52 (7.69%)  4 1/25 (4.00%)  1
Gastroenteritis  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Gastroenteritis viral  1  7/52 (13.46%)  7 1/25 (4.00%)  1
Influenza  1  10/52 (19.23%)  11 5/25 (20.00%)  8
Nasopharyngitis  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Pharyngitis  1  11/52 (21.15%)  14 3/25 (12.00%)  6
Pharyngitis streptococcal  1  1/52 (1.92%)  1 2/25 (8.00%)  2
Rhinitis  1  5/52 (9.62%)  6 1/25 (4.00%)  2
Sinusitis  1  5/52 (9.62%)  5 3/25 (12.00%)  6
Skin papilloma  1  9/52 (17.31%)  10 2/25 (8.00%)  2
Tinea infection  1  0/52 (0.00%)  0 2/25 (8.00%)  2
Upper respiratory tract infection  1  32/52 (61.54%)  80 14/25 (56.00%)  23
Viral infection  1  3/52 (5.77%)  4 0/25 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  5/52 (9.62%)  5 0/25 (0.00%)  0
Excoriation  1  8/52 (15.38%)  12 0/25 (0.00%)  0
Joint sprain  1  3/52 (5.77%)  4 0/25 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Aspartate aminotransferase increased  1  3/52 (5.77%)  3 0/25 (0.00%)  0
CD4 lymphocytes decreased  1  5/52 (9.62%)  5 0/25 (0.00%)  0
Glycosylated haemoglobin increased  1  5/52 (9.62%)  6 8/25 (32.00%)  8
Haematocrit decreased  1  4/52 (7.69%)  6 0/25 (0.00%)  0
Haemoglobin decreased  1  7/52 (13.46%)  10 1/25 (4.00%)  1
Lymphocyte count decreased  1  3/52 (5.77%)  4 0/25 (0.00%)  0
Platelet count decreased  1  4/52 (7.69%)  5 0/25 (0.00%)  0
White blood cell count decreased  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycaemia  1  4/52 (7.69%)  6 1/25 (4.00%)  1
Hypoglycaemia  1  21/52 (40.38%)  26 6/25 (24.00%)  7
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/52 (19.23%)  12 0/25 (0.00%)  0
Back pain  1  4/52 (7.69%)  7 0/25 (0.00%)  0
Musculoskeletal pain  1  2/52 (3.85%)  2 2/25 (8.00%)  2
Myalgia  1  2/52 (3.85%)  2 2/25 (8.00%)  2
Pain in extremity  1  7/52 (13.46%)  12 0/25 (0.00%)  0
Nervous system disorders     
Dizziness  1  8/52 (15.38%)  9 1/25 (4.00%)  1
Headache  1  30/52 (57.69%)  81 10/25 (40.00%)  26
Tremor  1  5/52 (9.62%)  7 1/25 (4.00%)  1
Psychiatric disorders     
Anxiety  1  11/52 (21.15%)  26 0/25 (0.00%)  0
Renal and urinary disorders     
Ketonuria  1  3/52 (5.77%)  3 3/25 (12.00%)  3
Reproductive system and breast disorders     
Dysmenorrhoea  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/52 (32.69%)  22 3/25 (12.00%)  4
Epistaxis  1  3/52 (5.77%)  5 0/25 (0.00%)  0
Nasal congestion  1  8/52 (15.38%)  8 5/25 (20.00%)  6
Oropharyngeal pain  1  12/52 (23.08%)  19 1/25 (4.00%)  1
Rhinitis allergic  1  7/52 (13.46%)  10 0/25 (0.00%)  0
Rhinorrhoea  1  3/52 (5.77%)  3 1/25 (4.00%)  1
Tonsillar hypertrophy  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Upper respiratory tract congestion  1  3/52 (5.77%)  3 4/25 (16.00%)  6
Skin and subcutaneous tissue disorders     
Acne  1  5/52 (9.62%)  5 1/25 (4.00%)  1
Dermatitis contact  1  5/52 (9.62%)  6 0/25 (0.00%)  0
Dry skin  1  8/52 (15.38%)  8 1/25 (4.00%)  1
Eczema  1  3/52 (5.77%)  5 0/25 (0.00%)  0
Erythema  1  8/52 (15.38%)  11 0/25 (0.00%)  0
Lipohypertrophy  1  2/52 (3.85%)  3 3/25 (12.00%)  4
Pruritus  1  15/52 (28.85%)  25 1/25 (4.00%)  1
Rash  1  41/52 (78.85%)  91 2/25 (8.00%)  2
Rash generalised  1  7/52 (13.46%)  7 0/25 (0.00%)  0
Rash papular  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Rash pruritic  1  3/52 (5.77%)  3 0/25 (0.00%)  0
Skin exfoliation  1  10/52 (19.23%)  12 0/25 (0.00%)  0
Vascular disorders     
Hypotension  1  12/52 (23.08%)  18 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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: NCT00129259     History of Changes
Other Study ID Numbers: DAIT ITN027AI
First Submitted: August 9, 2005
First Posted: August 11, 2005
Results First Submitted: June 21, 2013
Results First Posted: September 16, 2013
Last Update Posted: May 22, 2017