Status:
COMPLETED
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
Lead Sponsor:
CSL Behring
Conditions:
Primary Immune Deficiency
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB0...
Eligibility Criteria
Inclusion
- Subjects who have completed the preceding follow-up study ZLB07\_001CR.
- 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
- Pregnancy or nursing mother.
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01461018
Start Date
October 1 2011
End Date
July 1 2014
Last Update
December 2 2014
Active Locations (9)
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1
Study site
Nagoya, Aichi Pref., Japan, 466-8560
2
Study site
Chiba, Chiba Pref., Japan, 260-8677
3
Study site
Fukuoka, Fukuoka, Japan, 812-8582
4
Study site
Gifu, Gifu Pref., Japan, 502-8558