Phase 3 IGIV, 10% in Alzheimer´s Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01524887 |
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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 : May 19, 2021
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Sponsor:
Baxalta now part of Shire
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )
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| 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 |
Participant Flow
| 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 |
|---|---|---|---|
 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 |
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[1]
No subject completed the study as Baxter Healthcare terminated the study early.
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Baseline Characteristics
| Arm/Group Title | IGIV, 10% at High Dose (0.4 g/kg) | IGIV, 10% at Low Dose (0.2 g/kg) | Placebo Control | Total | |
|---|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
The baseline analysis population comprises treated subjects (=safety analysis set).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| 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) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 85 participants | 83 participants | 251 participants | |
| Female |
43 51.8%
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37 43.5%
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52 62.7%
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132 52.6%
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| Male |
40 48.2%
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48 56.5%
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31 37.3%
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119 47.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 85 participants | 83 participants | 251 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 1.2%
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0 0.0%
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1 0.4%
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| Asian |
0 0.0%
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1 1.2%
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3 3.6%
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4 1.6%
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| Native Hawaiian or Other Pacific Islander |
1 1.2%
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0 0.0%
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1 1.2%
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2 0.8%
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| Black or African American |
1 1.2%
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3 3.5%
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1 1.2%
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5 2.0%
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| White |
81 97.6%
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79 92.9%
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78 94.0%
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238 94.8%
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| More than one race |
0 0.0%
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1 1.2%
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0 0.0%
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1 0.4%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 83 participants | 85 participants | 83 participants | 251 participants |
| United States |
66 79.5%
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67 78.8%
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66 79.5%
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199 79.3%
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| Canada |
8 9.6%
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7 8.2%
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7 8.4%
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22 8.8%
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| Spain |
3 3.6%
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5 5.9%
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3 3.6%
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11 4.4%
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| Belgium |
6 7.2%
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5 5.9%
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6 7.2%
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17 6.8%
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| Japan |
0 0.0%
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1 1.2%
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1 1.2%
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2 0.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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: | Study Director |
| Organization: | Shire |
| Phone: | +1 866 842 5335 |
| EMail: | ClinicalTransparency@shire.com |
| Responsible Party: | Takeda ( Baxalta now part of Shire ) |
| ClinicalTrials.gov Identifier: | NCT01524887 |
| 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: | May 19, 2021 |