Status:
COMPLETED
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Lead Sponsor:
CSL Behring
Conditions:
Primary Immune Deficiency
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In ...
Eligibility Criteria
Inclusion
- Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
- Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
- Written informed consent
Exclusion
- Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
- Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
- Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
- Pregnancy or nursing mother
- A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
- Participation in a study with other investigational product during this study and within 3 months prior to screening
- Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01199705
Start Date
September 1 2010
End Date
November 1 2011
Last Update
December 12 2014
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Study site
Nagoya, Aichi Pref., Japan, 466-8560
2
Study site
Chiba, Chiba Pref., Japan, 260-8677
3
Study site
Gifu, Gifu Pref., Japan, 501-1194
4
Study site
Sapporo, Hokkaido, Japan, 060-8648