The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)
Intravenous infusion (regulated via a pump)
Subcutaneous infusion (regulated via a pump)
Medizinische Universität Wien / AHK Wien (General Hospital Vienna), Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria
Universitätsklinikum Erlangen, Medizinische Klinik 3
Erlangen, Germany
Acute serious bacterial infection rate defined as the mean number of acute serious bacterial infections per subject per year in the intent-to-treat population
Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections
Time frame: 1 year
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University Medical Centre Freiburg, Centre of Chronic Immunodeficiency, Divison of Rheumatology and Clinical Immunology
Freiburg im Breisgau, Germany
Universitätsklinikum Hamburg-Eppendorf, Kinderklinik
Hamburg, Germany
Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie
Hanover, Germany
Klinikum St. Georg GmbH, Klinik für Kinder- und Jugendmedizin
Leipzig, Germany
Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház, Gyermekhematológiai és Őssejt-transzplantációs Osztály
Budapest, Hungary
University of Debrecen, Medical and Health Science Center, Department of Infectious and Pediatric Immunology
Debrecen, Hungary
The Queen Silvia Children´s Hospital
Gothenburg, Sweden
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust, Immunology Department
Birmingham, United Kingdom
...and 2 more locations