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 ZLB07_001CR (NCT01458171).
Biological: Immune globulin subcutaneous (Human)
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Locations near you
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Full eligibility criteria for NCT01461018
Ages eligible for Study
up to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01461018
Nagoya city, Aichi Pref., Japan, 466-8560
Chiba city, Chiba Pref., Japan, 260-8677
Fukuoka city, Fukuoka, Japan, 812-8582
Gifu city, Gifu Pref., Japan, 502-8558
Sapporo city, Hokkaido, Japan, 060-8648
Moriguchi city, Osaka, Japan, 570-8507
Koshigaya city, Saitama Pref., Japan, 343-8555
Tokorozawa city, Saitama Pref., Japan, 359-8513
Bunkyo-ku, Tokyo Metropolitan, Japan, 113-8519
View full eligibility
Tris trial is registered with FDA with number: NCT01461018. The sponsor of the trial is CSL Behring and it is looking for 22 volunteers for the current phase.
Official trial title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
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