Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
NCT ID: NCT01461018
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2011-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IgPro20
Immune globulin subcutaneous (Human)
IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.
Interventions
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Immune globulin subcutaneous (Human)
IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and \<20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Exclusion Criteria
* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07\_001CR.
* Subjects who are planning to donate blood during the study.
* Known or suspected antibodies to the IMP, or to excipients of the IMP.
* Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
75 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Yusuke Watanabe
Role: STUDY_DIRECTOR
CSL Behring K.K.
Locations
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Study site
Nagoya, Aichi Pref., Japan
Study site
Chiba, Chiba Pref., Japan
Study site
Fukuoka, Fukuoka, Japan
Study site
Gifu, Gifu Pref., Japan
Study Site
Sapporo, Hokkaido, Japan
Study site
Moriguchi, Osaka, Japan
Study site
Koshigaya, Saitama Pref., Japan
Study site
Tokorozawa, Saitama Pref., Japan
Study site
Bunkyō City, Tokyo Metropolitan, Japan
Countries
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Other Identifiers
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IgPro20_3006
Identifier Type: -
Identifier Source: org_study_id