A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants...
Primary Immunodeficiency Diseases (PID)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 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.
Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients...
Primary Immune Deficiency DisorderCLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study
Primary Immune Deficiency DisorderPeriodontitisTitle: Investigation of neutrophil defects associated with periodontal disease and tooth loss in children. A clinical study. Objectives: The primary objective of this study is: To investigate presence of periodontal disease and response to periodontal treatment in children affected by neutrophil defects The secondary objectives of this study are: To investigate presence of other dental diseases in children affected by neutrophil defects To assess oral microbiological and inflammatory parameters in children affected by neutrophil defects Primary outcomes: The primary outcomes are (a) presence of periodontal disease as assessed by clinical factors: probing pocket depth, attachment level, bleeding on probing and radiographic bone loss) (b) microbiological and host response factors: detected in periodontal pockets and gingival crevicular fluid and (c) response to treatment Study sample: Children affected by neutrophil defects and meeting outlined inclusion and exclusion criteria Number of participants: 50 children Study design: This is a longitudinal treatment study. All participants will attend for 4-7 visits during the study as outlined below: Screening visit (visit 1): consent procedure, dental examination, saliva and plaque sampling Baseline visit (visit 2):, detailed periodontal examination, dental radiographs, sampling of gingival crevicular fluid and, if appropriate scaling, polishing and oral hygiene instructions Non-surgical periodontal treatment (visit 3A to 3D, max 4 sessions): oral hygiene instructions and supra- and sub-gingival debridement (under local anaesthesia if necessary) Follow-up Visit (visit 4, 4th to 7th visit) (six months following treatment): detailed dental examination, oral hygiene instructions, sampling of saliva, subgingival plaque and gingival crevicular fluid, tooth scaling and polishing.
TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID...
Primary Immune Deficiency DisorderHematopoietic Stem Cell TransplantationTreatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and unrelated donors in patients with primary immunodeficiency diseases
Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency...
Immunologic Deficiency SyndromeThe purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
Primary Immune Deficiency DiseaseThis is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
Primary Immune Deficiency (PID)This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.
Minipooled-IVIG in Primary Immunodeficiency Disease
Primary Immunodeficiencystudy the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG) Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) : Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate) Prevention of severe bacterial infection Improvement of general health(weight gain and mentality) Integration in to social live Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Primary Immunodeficiency DiseaseThe purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency...
Primary Immune Deficiency DisorderClinical phase 3 study to evaluate the efficacy, tolerability and safety of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases.