Clinical trial NCT01461018: Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
Official title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Deficiency
Keywords: Immune globulin subcutaneous
SCIG
Primary immunodeficiency
PID
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 22
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 ZLB07_001CR (NCT01458171).


Eligibility 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.

Primary outcomes:
measure: Annualized rate of infection episodes
timeFrame: Up to 36 months
Secondary outcomes:
measure: Number of subjects with adverse events (AEs)
timeFrame: Up to 36 months
measure: Percentage of subjects with adverse events (AEs)
timeFrame: Up to 36 months
measure: Rate of AEs per infusion
timeFrame: Up to 36 months
measure: Annualized rate of clinically documented serious bacterial infections (SBIs)
timeFrame: Up to 36 months
measure: Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
timeFrame: Up to 36 months
measure: Number of days of hospitalization due to infections
timeFrame: Up to 36 months
measure: Duration of use of antibiotics for infection prophylaxis and treatment
timeFrame: Up to 36 months
measure: Median serum IgG concentration
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Nagoya city
country: Japan
facility: Study site
state: Aichi Pref.
city: Chiba city
country: Japan
facility: Study site
state: Chiba Pref.
city: Fukuoka city
country: Japan
facility: Study site
state: Fukuoka
city: Gifu city
country: Japan
facility: Study site
state: Gifu Pref.
city: Sapporo city
country: Japan
facility: Study Site
state: Hokkaido
city: Moriguchi city
country: Japan
facility: Study site
state: Osaka
city: Koshigaya city
country: Japan
facility: Study site
state: Saitama Pref.
city: Tokorozawa city
country: Japan
facility: Study site
state: Saitama Pref.
city: Bunkyo-ku
country: Japan
facility: Study site
state: Tokyo Metropolitan
Study officials:
affiliation: CSL Behring K.K.
name: Yusuke Watanabe
role: STUDY_DIRECTOR
References: