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Trial record 84 of 747 for:    Area Under Curve AND meal

Inducing Remission in Type 1 Diabetes With Alefacept (T1DAL)

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ClinicalTrials.gov Identifier: NCT00965458
Recruitment Status : Terminated (Manufacturer discontinued production of Amevive®: business decision.)
First Posted : August 25, 2009
Results First Posted : January 7, 2015
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Juvenile Diabetes Research Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition New-onset Type 1 Diabetes Mellitus
Interventions Biological: Alefacept
Drug: Placebo
Enrollment 49
Recruitment Details Subjects were recruited during an approximate 84-week accrual period. Initially 66 subjects were planned; however, enrollment ended with 49 subjects as a result of the decision, unrelated to safety reasons, made by Astellas Pharma US, Inc. to discontinue manufacturing Amevive® (alefacept).
Pre-assignment Details Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment. Subjects were randomly assigned in a 2 to 1 (2:1) ratio to either the alefacept or placebo group.
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment. Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Period Title: Overall Study
Started 33 16
Completed 31 12
Not Completed 2 4
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             1             3
Withdrawal by Subject             0             1
Arm/Group Title Alefacept Placebo Total
Hide Arm/Group Description

Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Total of all reporting groups
Overall Number of Baseline Participants 33 16 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
<=18 years
17
  51.5%
8
  50.0%
25
  51.0%
Between 18 and 65 years
16
  48.5%
8
  50.0%
24
  49.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 16 participants 49 participants
20.3  (6.4) 19.5  (6.2) 20.0  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Female
16
  48.5%
4
  25.0%
20
  40.8%
Male
17
  51.5%
12
  75.0%
29
  59.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 16 participants 49 participants
33 16 49
2-Hour C-peptide Area Under the Curve Result in Response to Standardized Mixed Meal Tolerance Test   [1] 
Mean (Standard Deviation)
Unit of measure:  pmol/mL
Number Analyzed 33 participants 16 participants 49 participants
0.85  (0.42) 0.64  (0.22) 0.78  (0.38)
[1]
Measure 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 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 post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease.
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), Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:

Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Overall Number of Participants Analyzed 33 16
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.85  (0.42) 0.64  (0.22)
Week 52 0.86  (0.49) 0.53  (0.38)
Change from Baseline(Pre-treatment initiation) 0.02  (0.27) -0.12  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, 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 0.065
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 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), Week 52, and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Overall Number of Participants Analyzed 33 16
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.84  (0.36) 0.68  (0.23)
Week 52 0.86  (0.42) 0.52  (0.35)
Change from Baseline(Pre-treatment initiation) 0.02  (0.26) -0.16  (0.28)
Week 104 0.71  (0.50) 0.31  (0.30)
Change from Baseline (Pre-treatment initiation) -0.13  (0.37) -0.37  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Primary imputation method used for missing Week 52 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 0.019
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
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Primary imputation method used for missing Week 104 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 0.002
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
Method ANCOVA
Comments [Not Specified]
3.Secondary 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), Week 52, and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Overall Number of Participants Analyzed 33 16
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline (Pre-treatment initiation) 0.85  (0.42) 0.64  (0.22)
Week 52 0.86  (0.49) 0.53  (0.38)
Change from Baseline(Pre-treatment initiation) 0.02  (0.27) -0.12  (0.30)
Week 104 0.66  (0.50) 0.31  (0.29)
Change from Baseline (Pre-treatment initiation) -0.19  (0.34) -0.33  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Primary imputation method used for missing Week 52 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 0.065
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
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Primary imputation method used for missing Week 104 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 0.015
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
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Insulin Use in Units Per Kilogram Body Weight Per Day
Hide Description The need to use 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 initiation), Week 52, and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Overall Number of Participants Analyzed 33 16
Mean (Standard Deviation)
Unit of Measure: Units per day divided by weight in kg
Baseline (Pre-treatment initiation) 0.33  (0.20) 0.29  (0.17)
Week 52 0.36  (0.22) 0.48  (0.27)
Change from Baseline(Pre-treatment initiation) 0.02  (0.15) 0.17  (0.22)
Week 104 0.43  (0.19) 0.60  (0.24)
Change from Baseline (Pre-treatment initiation) 0.10  (0.16) 0.28  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Week 52 mean insulin use comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change 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 Alefacept, Placebo
Comments Week 104 mean insulin use comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Major Hypoglycemic Events Occurring From Randomization
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 to Week 52 and Week 52 to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Overall Number of Participants Analyzed 33 16
Measure Type: Number
Unit of Measure: Major Hypoglycemic Events
Baseline to Week 52 357 274
Week 52 to Week 104 252 251
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Hypoglycemic Events Occurring from Baseline to Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Hypoglycemic Events Occurring from Week 52 to Week 104
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups
Method Regression, Logistic
Comments [Not Specified]
6.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 level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.
Time Frame Baseline (Pre-treatment initiation), Week 52, and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Overall Number of Participants Analyzed 33 16
Mean (Standard Deviation)
Unit of Measure: HgbA1c percent (%)
Baseline (Pre-treatment initiation) 7.2  (1.5) 7.1  (1.5)
Week 52 6.9  (1.9) 7.2  (1.3)
Change from Baseline(Pre-treatment initiation) -0.1  (1.4) 0.0  (1.3)
Week 104 7.4  (1.6) 7.5  (1.3)
Change from Baseline (Pre-treatment initiation) 0.4  (1.5) 0.3  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alefacept, Placebo
Comments Week 52 mean HbA1C comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change 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 Alefacept, Placebo
Comments Week 104 mean HbA1C comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.942
Comments P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable
Method ANCOVA
Comments [Not Specified]
Time Frame Enrollment through participant's last visit, up to Week 104
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
All-Cause Mortality
Alefacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alefacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/16 (0.00%)    
Infections and infestations     
Gastroenteritis  1  1/33 (3.03%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alefacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/33 (100.00%)      16/16 (100.00%)    
Blood and lymphatic system disorders     
Leukopenia  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Lymphadenopathy  1  4/33 (12.12%)  13 2/16 (12.50%)  8
Lymphopenia  1  3/33 (9.09%)  3 0/16 (0.00%)  0
Neutropenia  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Ear and labyrinth disorders     
Cerumen impaction  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Ear pain  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Endocrine disorders     
Hypothyroidism  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Eye disorders     
Conjunctivitis  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Episcleritis  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/33 (9.09%)  4 0/16 (0.00%)  0
Abdominal pain upper  1  3/33 (9.09%)  8 2/16 (12.50%)  3
Diarrhoea  1  5/33 (15.15%)  5 2/16 (12.50%)  3
Haematochezia  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Nausea  1  7/33 (21.21%)  8 4/16 (25.00%)  5
Toothache  1  2/33 (6.06%)  4 0/16 (0.00%)  0
Vomiting  1  5/33 (15.15%)  6 2/16 (12.50%)  2
General disorders     
Chills  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Fatigue  1  4/33 (12.12%)  5 1/16 (6.25%)  1
Influenza like illness  1  2/33 (6.06%)  7 2/16 (12.50%)  3
Pain  1  1/33 (3.03%)  1 2/16 (12.50%)  2
Pyrexia  1  3/33 (9.09%)  3 2/16 (12.50%)  3
Immune system disorders     
Allergy to arthropod bite  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Seasonal allergy  1  4/33 (12.12%)  4 2/16 (12.50%)  3
Infections and infestations     
Ear infection  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Furuncle  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Gastroenteritis  1  4/33 (12.12%)  4 2/16 (12.50%)  5
Gastroenteritis viral  1  3/33 (9.09%)  3 2/16 (12.50%)  2
Hordeolum  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Infection  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Nasopharyngitis  1  9/33 (27.27%)  16 3/16 (18.75%)  4
Oral herpes  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Paronychia  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Pharyngitis  1  6/33 (18.18%)  7 0/16 (0.00%)  0
Pharyngitis streptococcal  1  1/33 (3.03%)  1 1/16 (6.25%)  2
Rash pustular  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Rhinitis  1  2/33 (6.06%)  4 0/16 (0.00%)  0
Sinusitis  1  6/33 (18.18%)  9 3/16 (18.75%)  9
Staphylococcal skin infection  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Tinea pedis  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Upper respiratory tract infection  1  19/33 (57.58%)  40 7/16 (43.75%)  14
Viral infection  1  3/33 (9.09%)  4 2/16 (12.50%)  2
Vulvovaginal candidiasis  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Arthropod bite  1  1/33 (3.03%)  2 1/16 (6.25%)  1
Contusion  1  6/33 (18.18%)  6 4/16 (25.00%)  5
Excoriation  1  4/33 (12.12%)  5 1/16 (6.25%)  1
Laceration  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Limb injury  1  2/33 (6.06%)  2 1/16 (6.25%)  1
Muscle strain  1  2/33 (6.06%)  2 1/16 (6.25%)  1
Nail avulsion  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Subcutaneous haematoma  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Investigations     
Alanine aminotransferase increased  1  7/33 (21.21%)  14 3/16 (18.75%)  4
Aspartate aminotransferase increased  1  6/33 (18.18%)  8 2/16 (12.50%)  4
CD4 lymphocytes decreased  1  2/33 (6.06%)  6 0/16 (0.00%)  0
Cardiac murmur  1  3/33 (9.09%)  3 0/16 (0.00%)  0
Hepatic enzyme increased  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Low density lipoprotein increased  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Neutrophil count abnormal  1  0/33 (0.00%)  0 1/16 (6.25%)  1
White blood cell count decreased  1  3/33 (9.09%)  3 1/16 (6.25%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  30/33 (90.91%)  600 15/16 (93.75%)  516
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/33 (12.12%)  5 1/16 (6.25%)  1
Back pain  1  4/33 (12.12%)  7 2/16 (12.50%)  2
Bone pain  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Muscle spasms  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Muscle twitching  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Muscular weakness  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Myalgia  1  3/33 (9.09%)  3 1/16 (6.25%)  9
Neck pain  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Pain in extremity  1  1/33 (3.03%)  1 3/16 (18.75%)  3
Nervous system disorders     
Dizziness  1  3/33 (9.09%)  3 2/16 (12.50%)  2
Headache  1  14/33 (42.42%)  32 5/16 (31.25%)  9
Migraine  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Muscle contractions involuntary  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Presyncope  1  1/33 (3.03%)  1 1/16 (6.25%)  2
Sinus headache  1  0/33 (0.00%)  0 1/16 (6.25%)  2
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/33 (21.21%)  9 2/16 (12.50%)  3
Laryngeal inflammation  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Nasal congestion  1  4/33 (12.12%)  5 1/16 (6.25%)  1
Oropharyngeal pain  1  7/33 (21.21%)  11 2/16 (12.50%)  2
Paranasal sinus hypersecretion  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Pharyngeal erythema  1  2/33 (6.06%)  2 2/16 (12.50%)  2
Rhinitis allergic  1  4/33 (12.12%)  4 1/16 (6.25%)  1
Rhinorrhoea  1  1/33 (3.03%)  1 1/16 (6.25%)  2
Sinus congestion  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Sneezing  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Tonsillar hypertrophy  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Upper respiratory tract congestion  1  3/33 (9.09%)  3 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Acne  1  4/33 (12.12%)  6 1/16 (6.25%)  1
Alopecia  1  1/33 (3.03%)  1 1/16 (6.25%)  1
Dermatitis contact  1  2/33 (6.06%)  2 1/16 (6.25%)  1
Ecchymosis  1  0/33 (0.00%)  0 1/16 (6.25%)  2
Hyperhidrosis  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Lipohypertrophy  1  1/33 (3.03%)  2 2/16 (12.50%)  4
Pain of skin  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Rash  1  2/33 (6.06%)  3 1/16 (6.25%)  2
Rash macular  1  0/33 (0.00%)  0 1/16 (6.25%)  2
Skin discolouration  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Skin exfoliation  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Skin hypopigmentation  1  0/33 (0.00%)  0 1/16 (6.25%)  1
Skin lesion  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Vascular disorders     
Hypertension  1  2/33 (6.06%)  2 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Enrollment ended early with 49 subjects (instead of the planned 66) as a result of the decision, unrelated to safety reasons, made by Astellas Pharma US, Inc. to discontinue manufacturing Amevive® (alefacept).
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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00965458     History of Changes
Other Study ID Numbers: DAIT ITN045AI
First Submitted: August 22, 2009
First Posted: August 25, 2009
Results First Submitted: December 19, 2014
Results First Posted: January 7, 2015
Last Update Posted: July 6, 2017