N/A N=314 Primary Immunodeficiency in Kuwait
Primary Immune Deficiency Disorder
Primary: Number of Participants With Different Epidemiological Features — 287; 100; 68; 56 patients
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=63 Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Primary Immune Deficiency Disorders (PIDD)
Primary: Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment — 0.035 SBIs Per Total Person-Years
Phase 3 N=59 Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Primary Immune Deficiency Disorder
Primary: Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)) — 0 SBIs/subject/year
Phase 3 N=75 Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Primary Immunodeficiency
Primary: Annual Rate of Occurrence of Serious Bacterial Infections (SBI) — 0; 0.01; 0; 0.03 Rate of events per subject per year
Phase 3 N=55 Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Agammaglobulinemia · IgG Deficiency · Common Variable Immunodeficiency
Primary: The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). — 0.073; 0.141; 0.150 Proportion of infusions
Phase 3 N=21 Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Primary Immune Deficiency
Primary: Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) — 0.06 infections per subject year
Phase 4 N=18 Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Common Variable Immunodeficiency · Agammaglobulinemia
Primary: Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 — 0.944 proportion of patients
Phase 3 N=77 Phase 2/3 Study of IGSC, 20% in PIDD
Primary Immunodeficiency Diseases (PID)
Primary: Rate of Acute Serious Bacterial Infections Per Year (ASBI) — 0.012 Estimated infections/ year — p=<0.0001
Phase 3 N=49 Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
Primary Immune Deficiency
Primary: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) — 0.00 SBIs per subject year
Phase 3 N=17 A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
Primary Immunodeficiency Diseases (PID)
Primary: Epoch 2: Total Serum Trough Levels of Immune Globulin G (IgG) Antibodies During Period 2 — 8.56 grams per liter (g/L)
Phase 3 N=16 A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)
Primary Immunodeficiency Diseases (PID)
Primary: Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 — 9.372; 8.741; 8.929; 9.150 grams/Liter (g/L)
Phase 3 N=49 Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Immunologic Deficiency Syndromes
Primary: The Incidence of Acute Serious Bacterial Infections (SBI) — 0.04; 0; 0.02 Number of events per patient per year
Phase 3 N=51 Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Common Variable Immunodeficiency · X-linked Agammaglobulinemia · Autosomal Recessive Agammaglobulinemia
Primary: Total Serum IgG Trough Levels — 8.10; 7.49 g/L
Phase 3 N=49 Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
Primary Immunodeficiency Diseases (PID)
Primary: Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part…
Phase 3 N=47 Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Primary Immunodeficiency Disease
Primary: Incidence Rate of Acute Serious Bacterial Infections (ABSIs) — 0.0; 0.0 infections per participant-year
Phase 3 N=45 Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Primary Immunodeficiency · Agammaglobulinemia · Hypogammaglobulinemia
Primary: Incidence of Acute, Serious Bacterial Infections in the Total ITT Population. — 0.04 ASBI's/person-year
Phase 3 N=50 Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.
Primary Immunodeficiency · Common Variable Hypogammaglobulinemia · X-linked Hypogammaglobulinemia
Primary: Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease. — 0 SABIs/subject/year — p=0.01
Phase 4 N=42 Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
Primary Immunodeficiency Diseases (PID)
Primary: Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) — 1; 0 Participants
Phase 3 N=81 Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
Primary Immunodeficiency Disease
Primary: Rate of Acute Serious Bacterial Infections — 0.015 SBI rate per subject-year
N/A N=1,086 Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients
Secondary Immunodeficiencies (SID)
Primary: Guideline Adherence (GLAD) — 889; 75; 122 Participants
Phase 3 N=98 TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID
Primary Immune Deficiency Disorder · Hematopoietic Stem Cell Transplantation
Primary: Overall Survival — 86; 86; 87 percentage of survival probability — p=0.95
Phase 3 N=25 Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases
Primary Immune Deficiency Disorder
Primary: Number of Serious Bacterial Infections Per Person-Year on Treatment — 0 SBI per patient year
Phase 2 N=47 Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)
Hemophagocytic Lymphohistiocytosis · Chronic Active Epstein-Barr Virus Infection · Chronic Granulomatous Disease
Primary: Percentage of Participants With Overall Survival (OS) — 80.4; 66.7 percentage of participants
Phase 3 N=44 Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
Primary Immunodeficiency Diseases (PID)
Primary: Rate Represented as Mean Number of Acute Serious Bacterial Infections (ASBI) Per Participant-year — 0.04 ASBI per participant-year
Phase 3 N=64 Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
Primary Immune Deficiency Disorder
Primary: IgG Trough Levels From Baseline to End of Study (28 Weeks) — 0.144; 0.065; -0.593 g/L
Phase 3 N=87 Gammagard Liquid and rHuPH20 in PID
Primary Immunodeficiency Diseases (PID)
Primary: Validated Acute Serious Bacterial Infection (VASBI) Rate — 0.025 Estimated infections/year — p=<0.0001
Phase 3 N=25 Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Primary Immune Deficiency
Primary: IgG Trough Level — 1.09; 1.11 Ratio of Geometric Means
Early Phase 1 N=48 Donor Stem Cell Transplantation for Congenital Immunodeficiencies
Inherited Immune Deficiencies
Primary: Stem Cell Transplant Engraftment — 7; 31; 3; 0 Participants
Phase 4 N=25 A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinemia
Primary: Adverse Events — 2 participants — p=0.01
Phase 3 N=40 Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Primary Immunodeficiency (PID)
Primary: Total Serum IgG Trough Levels — 7.97 g/L