Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects with Primary Immunodeficiency (Japan Study)

Conditions: Primary Immune Deficiency
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-003409-13-Outside-EU/EEA

Lead Sponsor: CSL Behring

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 22

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: Not applicable;Primary end point(s): Annualized rate of infection episodes;Timepoint(s) of evaluation of this end point: Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Up to 36 months;Secondary end point(s): - Number of subjects with adverse events (AEs)<br> - Percentage of subjects with adverse events (AEs)<br> - Rate of AEs per infusion<br> - Annualized rate of clinically documented serious bacterial infections (SBIs)<br> - Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections<br> - Number of days of hospitalization due to infections<br> - Duration of use of antibiotics for infection prophylaxis and treatment<br> - Median serum IgG concentration