Primary Immunodeficiency
Conditions
Interventions
investigational material(s)
Generic name etc : Immune Globulin Subcutaneous (Human) IgPro20
INN of investigational material : -
Therapeutic category code : 634 Human blood preparations
Dosage and Admi
Sponsors
CSL Behring K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy 2. 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 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy. 2. Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening 3. Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma. 4. Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening. 5. Pregnancy or nursing mother. 6. 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. 7. Participation in a study with other investigational product during this study and within 3 months prior to screening. 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory IgG trough levels The ratio of the geometric means of trough levels of 3 intravenous immuneglobulin (IVIG) infusions will be compared with the trough levels for 3 subcutaneous immune globulin (SCIG) infusions measured at steady-state (weeks 16, 20 and 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Number of infection episodes (serious and non-serious), 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 Assessed from concomitant medications documented in the subject case report form (CRF) | — |
Countries
Japan
Outcome results
None listed