Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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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: NCT02027701 |
Recruitment Status :
Completed
First Posted : January 6, 2014
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
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Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Intervention |
Biological: IgPro20 |
Enrollment | 82 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | IgPro20 |
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20% liquid formulation (200 mg/mL) of human normal immunoglobulin administered SC weekly at 0.2 g/kg, and subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20. |
Period Title: Overall Study | |
Started | 82 |
Completed | 66 |
Not Completed | 16 |
Reason Not Completed | |
Adverse Event | 3 |
Lack of Efficacy | 8 |
Physician Decision | 2 |
Withdrawal by Subject | 3 |
Baseline Characteristics
Arm/Group Title | IgPro20 | |
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20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg. | |
Overall Number of Baseline Participants | 82 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 82 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
55 67.1%
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>=65 years |
27 32.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 82 participants | |
57.57 (13.224) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 82 participants | |
Female |
32 39.0%
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Male |
50 61.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 82 participants | |
Hispanic or Latino |
14 17.1%
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Not Hispanic or Latino |
66 80.5%
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Unknown or Not Reported |
2 2.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 82 participants | |
American Indian or Alaska Native |
1 1.2%
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Asian |
10 12.2%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
70 85.4%
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More than one race |
0 0.0%
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Unknown or Not Reported |
1 1.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 82 participants |
Canada | 7 | |
Netherlands | 1 | |
United States | 9 | |
Czechia | 2 | |
Japan | 10 | |
Italy | 8 | |
United Kingdom | 4 | |
Australia | 1 | |
France | 1 | |
Germany | 29 | |
Spain | 10 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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.
CSL agreements may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | Clinical Trial Disclosure Manager |
Organization: | CSL Behring |
Phone: | Use email contact |
EMail: | clinicaltrials@cslbehring.com |
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT02027701 |
Other Study ID Numbers: |
IgPro20_3004 2013-004157-24 ( EudraCT Number ) |
First Submitted: | January 3, 2014 |
First Posted: | January 6, 2014 |
Results First Submitted: | July 9, 2018 |
Results First Posted: | October 2, 2018 |
Last Update Posted: | October 2, 2018 |