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Phase 3 IGIV, 10% in Alzheimer´s Disease

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ClinicalTrials.gov Identifier: NCT01524887
Recruitment Status : Terminated (The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.)
First Posted : February 2, 2012
Results First Posted : March 31, 2015
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alzheimer´s Disease
Interventions Biological: Immune Globulin Intravenous (Human), 10% Solution
Biological: Human albumin 0.25%
Enrollment 508
Recruitment Details Enrollment was conducted at 58 clinical sites worldwide.
Pre-assignment Details Of 508 enrolled subjects, 303 met entry criteria. 42 subjects discontinued before randomization due to study termination. Of 261 randomized subjects, 10 subjects discontinued before receiving treatment (7 study termination, 2 withdrawal by subject, 1 withdrawal by caregiver). Number of subjects who received treatment (IVIG,10% or placebo) = 251.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Period Title: Overall Study
Started 85 90 86
Received Treatment 83 85 83
Completed 0 [1] 0 [1] 0 [1]
Not Completed 85 90 86
Reason Not Completed
Withdrawal by Subject             6             2             3
Adverse Event             5             1             1
Protocol Violation             0             0             1
Study termination             73             87             79
Withdrawal by Caregiver             0             0             2
Use of prohibited medication             1             0             0
[1]
No subject completed the study as Baxter Healthcare terminated the study early.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control Total
Hide Arm/Group Description Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months Total of all reporting groups
Overall Number of Baseline Participants 83 85 83 251
Hide Baseline Analysis Population Description
The baseline analysis population comprises treated subjects (=safety analysis set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 85 participants 83 participants 251 participants
72.0  (8.36) 69.9  (8.59) 70.6  (9.98) 70.8  (9.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 83 participants 251 participants
Female
43
  51.8%
37
  43.5%
52
  62.7%
132
  52.6%
Male
40
  48.2%
48
  56.5%
31
  37.3%
119
  47.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 83 participants 251 participants
American Indian or Alaska Native
0
   0.0%
1
   1.2%
0
   0.0%
1
   0.4%
Asian
0
   0.0%
1
   1.2%
3
   3.6%
4
   1.6%
Native Hawaiian or Other Pacific Islander
1
   1.2%
0
   0.0%
1
   1.2%
2
   0.8%
Black or African American
1
   1.2%
3
   3.5%
1
   1.2%
5
   2.0%
White
81
  97.6%
79
  92.9%
78
  94.0%
238
  94.8%
More than one race
0
   0.0%
1
   1.2%
0
   0.0%
1
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 83 participants 251 participants
United States 66 67 66 199
Canada 8 7 7 22
Spain 3 5 3 11
Belgium 6 5 6 17
Japan 0 1 1 2
1.Primary Outcome
Title Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)
Hide Description

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.

Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 21 28 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
4.0  (6.44) 4.4  (8.56) 3.1  (4.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.4
Confidence Interval 95%
-1.0 to 3.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.370
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.0
Confidence Interval 95%
-1.2 to 3.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory
Hide Description

The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.

Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.

Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 21 29 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-8.1  (7.36) -5.0  (11.64) -3.8  (9.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -3.9
Confidence Interval 95%
-7.4 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.9
Confidence Interval 95%
-4.2 to 2.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title ADCS-Clinical Global Impression of Change (CGIC) at 18 Months
Hide Description The ADCS-CGIC is a validated categorical measure of change in a participant’s global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).
Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 10 16 16
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
4.3
(3.7 to 4.8)
4.4
(4.0 to 4.9)
4.5
(4.1 to 5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.2
Confidence Interval 95%
-1.0 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.1
Confidence Interval 95%
-0.7 to 0.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)
Hide Description The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 21 29 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.3  (5.76) 3.8  (12.44) 0.6  (5.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.1
Confidence Interval 95%
-2.6 to 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 3.7
Confidence Interval 95%
0.3 to 7.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement
Hide Description [Not Specified]
Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 9 15 17
Mean (Standard Deviation)
Unit of Measure: mm^3
0.00065  (0.00059) 0.00057  (0.00070) 0.00067  (0.00163)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.00026
Confidence Interval 95%
-0.00126 to 0.00073
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.940
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 0.00003
Confidence Interval 95%
-0.00080 to 0.00086
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)
Hide Description The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant´s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52, with lower scores associated with a lower quality of life.
Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 16 26 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (4.43) 0.4  (3.68) 0.1  (4.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at High Dose (0.4 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.5
Confidence Interval 95%
-2.8 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV, 10% at Low Dose (0.2 g/kg), Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.981
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.0
Confidence Interval 95%
-2.0 to 2.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)
Hide Description The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.
Time Frame Baseline to 9 Months (actual time frame)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 19 27 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
5.8  (4.13) 1.9  (6.66) 1.4  (5.97)
8.Secondary Outcome
Title Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Throughout the study period: 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Measure Type: Number
Unit of Measure: participants
Participants with product-related AEs (incl SAEs) 31 25 16
Participants with product-related non-serious AEs 30 25 16
Participants with product-related SAEs 1 0 1
9.Secondary Outcome
Title Number of Participants Experiencing Any AEs and/or SAEs
Hide Description [Not Specified]
Time Frame Throughout the study period: 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Measure Type: Number
Unit of Measure: participants
Participants with AEs (incl SAEs) 57 54 49
Participants with non-serious AEs 55 53 48
Participants with serious AEs (SAEs) 5 7 7
10.Secondary Outcome
Title Number of Infusions Temporally Associated With AEs and/or SAEs
Hide Description A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.
Time Frame During or within 72 hours of completion of an infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Overall Number of Units Analyzed
Type of Units Analyzed: Total number of infusions administered
817 935 1023
Measure Type: Number
Unit of Measure: infusions
72 80 47
11.Secondary Outcome
Title Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion
Hide Description [Not Specified]
Time Frame During or within 7 days of completion of an infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Overall Number of Units Analyzed
Type of Units Analyzed: Total number of infusions administered
817 935 1023
Measure Type: Number
Unit of Measure: infusions
97 107 72
12.Secondary Outcome
Title Number of Infusions Causally Associated With AEs and/or SAEs
Hide Description [Not Specified]
Time Frame Throughout the study period: 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Overall Number of Units Analyzed
Type of Units Analyzed: Total number of infusions administered
817 935 1023
Measure Type: Number
Unit of Measure: infusions
46 48 30
13.Secondary Outcome
Title Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE
Hide Description [Not Specified]
Time Frame Throughout infusions, approximately 2-5 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description:
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
Overall Number of Participants Analyzed 83 85 83
Overall Number of Units Analyzed
Type of Units Analyzed: Total number of infusions administered
817 935 1023
Measure Type: Number
Unit of Measure: infusions
7 2 1
Time Frame Throughout the study period. The study was terminated early and no subject completed 18 months of treatment as planned per protocol. The duration of exposure to the investigational product varied for each subject.
Adverse Event Reporting Description The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product (High Dose group: 83, Low Dose group: 85, Placebo group: 83).
 
Arm/Group Title IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Hide Arm/Group Description Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
All-Cause Mortality
IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/83 (6.02%)      7/85 (8.24%)      7/83 (8.43%)    
Cardiac disorders       
Angina Pectoris * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 1/83 (1.20%)  1
Atrial Fibrillation * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Gastrointestinal disorders       
Food Poisoning * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 1/83 (1.20%)  1
Infections and infestations       
Gastroenteritis Viral * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 1/83 (1.20%)  1
Human Ehrlichiosis * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Pneumonia * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Urinary Tract Infection * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Injury, poisoning and procedural complications       
Alcohol Poisoning * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Fall * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 2/83 (2.41%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 2/83 (2.41%)  2
Nervous system disorders       
Encephalopathy * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Headache * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Hemiparesis * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Spinal Cord Disorder * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Syncope * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 1/83 (1.20%)  1
Transient Ischaemic Attack * 1  0/83 (0.00%)  0 0/85 (0.00%)  0 1/83 (1.20%)  1
Psychiatric disorders       
Abnormal Behaviour * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Mental Status Changes * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 0/83 (0.00%)  0
Renal and urinary disorders       
Calculus Ureteric * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Hematuria * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Renal Failure Acute * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
Vascular disorders       
Thrombophlebitis Superficial * 1  0/83 (0.00%)  0 1/85 (1.18%)  1 0/83 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IGIV, 10% at High Dose (0.4 g/kg) IGIV, 10% at Low Dose (0.2 g/kg) Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/83 (36.14%)      33/85 (38.82%)      30/83 (36.14%)    
Gastrointestinal disorders       
Nausea * 1  5/83 (6.02%)  7 5/85 (5.88%)  7 3/83 (3.61%)  5
Diarrhoea * 1  1/83 (1.20%)  1 0/85 (0.00%)  0 10/83 (12.05%)  15
General disorders       
Fatigue * 1  5/83 (6.02%)  11 10/85 (11.76%)  15 6/83 (7.23%)  12
Infusion Site Extravasation * 1  5/83 (6.02%)  10 6/85 (7.06%)  6 4/83 (4.82%)  4
Infections and infestations       
Upper Respiratory Tract Infection * 1  3/83 (3.61%)  4 5/85 (5.88%)  6 5/83 (6.02%)  5
Nasopharyngitis * 1  0/83 (0.00%)  0 3/85 (3.53%)  3 5/83 (6.02%)  5
Musculoskeletal and connective tissue disorders       
Back Pain * 1  5/83 (6.02%)  7 5/85 (5.88%)  8 3/83 (3.61%)  3
Pain in Extremity * 1  5/83 (6.02%)  5 1/85 (1.18%)  1 0/83 (0.00%)  0
Nervous system disorders       
Headache * 1  10/83 (12.05%)  14 11/85 (12.94%)  19 5/83 (6.02%)  6
Skin and subcutaneous tissue disorders       
Rash * 1  7/83 (8.43%)  8 8/85 (9.41%)  9 1/83 (1.20%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
The primary and secondary outcome measures were originally planned to be assessed at 18 months. However, as the study was terminated early, an analysis was completed at 9 months instead, in a subset of subjects who had received 9 months of treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (eg, for intellectual property protection).
Results Point of Contact
Name/Title: Kathy Tobias, MD, Global Medical Dir, Biotherapeutics, Neurology
Organization: Baxter Healthcare Corporation
Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT01524887     History of Changes
Other Study ID Numbers: 161003
2011-000914-21 ( EudraCT Number )
First Submitted: January 20, 2012
First Posted: February 2, 2012
Results First Submitted: February 3, 2015
Results First Posted: March 31, 2015
Last Update Posted: November 24, 2017