Status:
COMPLETED
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Lead Sponsor:
CSL Behring
Conditions:
Primary Immune Deficiency Disorder
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06\_002CR (N...
Eligibility Criteria
Inclusion
- Subjects who have participated in study ZLB06\_002CR and who have tolerated IgPro20 well.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.
Exclusion
- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration \>0.2 g/L or urine protein ++ by dipstick).
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06\_002CR.
- Subjects who are planning to donate blood during the study.
- Re-entry of subjects previously participating in the current follow-up study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01458171
Start Date
April 1 2011
End Date
April 1 2012
Last Update
April 9 2013
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