a study of immune globulin subcutaneous (human), 20% solution (igsc, 20%) in japanese participants with primary immunodeficiency diseases (pid)

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: in this study, japanese participants with primary immunodeficiency diseases were treated with immune globulin subcutaneous (human), 20% solution, (igsc, 20%). this study will be in 3 parts: part 1: infusions with immunoglobulin intravenous (igiv) every 3 or 4 weeks for 13 weeks. part 2: participants will switch to weekly subcutaneous infusions with igsc, 20% for 24 weeks. part 3: a subset will receive biweekly subcutaneous infusions with igsc, 20% for 12 weeks. the main aim of the study is to assess base levels of immunoglobulin globulin g (igg) levels in the blood of the participants after weekly and biweekly treatment with igsc, 20% (in parts 2 and 3 of the study). their pid will be treated by their doctor according to their doctor's usual clinical practice.

this study consists of 3 treatment parts (epoch 1, 2, 3). the total evaluation period of the study will be 57 weeks in which screening period is for 2-8 weeks and epoch 1 is from week 8 to week 21, epoch 2 is from week 21 to week 45, epoch 3 is from week 45 to week 57. each participant will receive igiv treatment in epoch 1 for a total of 13 weeks, then switch to weekly subcutaneous (sc) treatment with igsc, 20% in epoch 2 for a total of 24 weeks and will continue into epoch 3 for a total of 12 weeks of biweekly sc treatment with igsc, 20%. drug dose in epoch 2 and epoch 3 will be adjusted so that it will be an equivalent weekly dose of the dose administered in epoch 1 and twice the dose administrated in epoch 2 respectively. epoch 2 will contain two periods, period 1: dose adjustment period (first 12 weeks) and period 2: evaluation period (second 12 weeks).

Eligibility criteria:
inclusion criteria: * be of japanese descent, defined as born in japan and having japanese parents and japanese maternal and paternal grandparents. * participants must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin replacement. the diagnosis must be confirmed by the medical director prior to treatment with igiv. * participant is 2 years or older at the time of screening. * written informed consent is obtained from either the participants or the participants legally authorized representative prior to any study-related procedures and study product administration. * participant has been receiving a consistent dose of igiv over a period of at least 3 months prior to screening equivalent to approximately 200-600 mg/kg-body weight (bw) per 3- 4 week period, as according to the product package insert * participant has a serum trough level of igg \>= 5 gram per liter (g/l) at screening. * participant has not had a serious bacterial infection within the 3 months prior to screening. * participant is willing and able to comply with the requirements of the protocol. exclusion criteria: * participant has a known history of or is positive at screening for one or more of the following: hepatitis b surface antigen (hbsag), polymerase chain reaction (pcr) for hepatitis c virus (hcv), pcr for human immunodeficiency virus (hiv) type 1/2. * abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): * persistent alanine aminotransferase (alt) and aspartate amino transferase (ast) \> 2.5 times the upper limit of normal (uln) for the testing laboratory * persistent severe neutropenia (defined as an absolute neutrophil count \[anc\] \<= 500/milli cubic meter \[mm\^3\]). * participant has presence of renal function impairment defined by estimated glomerular filtration rate (egfr) is \<60 milliliter per minute/ 1.73 square meter (ml/min/1.73m\^2). * participant has been diagnosed with or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years. * participant is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening or a history of thrombophilia. * participant has abnormal protein loss (protein losing enteropathy, nephrotic syndrome). * participant has anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site. * participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following iv immunoglobulin, sc immunoglobulin, and/or immune serum globulin (isg) infusions. * participant has immunoglobulin a (iga) deficiency (iga less than 0.07 g/l), known anti iga antibodies, and a history of hypersensitivity. * participant is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening. * participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening. * participant has a bleeding disorder, or a platelet count less than 20,000/ microliter (mcl), or, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy. * participant has total protein \> 9 gram per deciliter (g/dl) or myeloma, or macroglobulinemia (igm) or paraproteinemia. * women of childbearing potential meeting any one of the following criteria: * participant presents with a positive pregnancy test. * participant is breast feeding. * participant intends to begin nursing during the course of the study. * participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom \[for male partner\] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study. * participant has participated in another clinical study and has been exposed to an ip or device within 30 days prior to study enrollment. * participant is scheduled to participate in another non-observational (interventional) clinical study involving an ip or device during the course of the study. * participant has severe dermatitis that would preclude adequate sites for safe product administration.