Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
Information source: CSL Behring
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Immune Deficiency
Intervention: Immune globulin subcutaneous (Human) (Biological)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: CSL Behring Official(s) and/or principal investigator(s):
Shoko Hakamazuka, Study Director, Affiliation: CSL Behring K.K.
Overall contact:
Clinical R&D Japan, Email: chiken@cslbehring.com
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 ZLB07_001CR (NCT01458171).
Clinical Details
Official title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Annualized rate of infection episodes
Secondary outcome: Number of subjects with adverse events (AEs)Percentage of subjects with adverse events (AEs) Rate of AEs per infusion Annualized rate of clinically documented serious bacterial infections (SBIs) Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections Number of days of hospitalization due to infections Duration of use of antibiotics for infection prophylaxis and treatment Median serum IgG concentration
Eligibility
Minimum age: N/A.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Clinical R&D Japan, Email: chiken@cslbehring.com
Study site, Nagoya city, Aichi Pref. 466-8560, Japan
Study site, Chiba city, Chiba Pref. 260-8677, Japan
Study site, Gifu city, Gifu Pref. 502-8558, Japan
Study Site, Sapporo city, Hokkaido 060-8648, Japan
Study site, Fukuoka city, Osaka 812-8582, Japan
Study site, Moriguchi city, Osaka 570-8507, Japan
Study site, Koshigaya city, Saitama Pref. 343-8555, Japan
Study site, Tokorozawa city, Saitama Pref. 359-8513, Japan
Study site, Bunkyo-ku, Tokyo Metropolitan 113-8519, Japan
Additional Information
Starting date: October 2011
Last updated: October 26, 2011
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