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
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
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 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 2 N=31 Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Primary: Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month — 0 Participants
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
N/A N=308 COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
Immunodeficiencies · Immune Dysregulations
Primary: Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform — 0.447333; 2.10678…
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 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=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 2 N=10 MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID
Severe Combined Immunodeficiency
Primary: Number of Participants With Adverse Events — 10; 9; 0; 10 participants
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=21 A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Immunologic Deficiency Syndrome
Primary: Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG) — 7549; 6706 mg*hr/ml
Phase 3 N=52 Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
Primary Immunodeficiency
Primary: AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval — 207921.5; 213141.4 h*mg/dL
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
N/A N=133 Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Infections After Lung Transplant
Primary: The Primary Outcome Will be the Total Number of Days With Pneumonia. — 1714; 51 Number of days
Phase 2 N=6 Immune Tolerance Study With Aldurazyme® (Laronidase)
Mucopolysaccharidosis I
Primary: Number of Participants Who Achieved Immune Tolerance Induction — 0; 1 participants
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=61 Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
Primary Immunodeficiency
Primary: Rate of Serious Bacterial Infection (SBI) Per Participant Per Year — 0; 0.023; 0.017 Rate of events per participant 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=271 Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients
Human Papilloma Virus · Hiv · Organ Transplants
Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines — 100; 64.2; 100; 70.7 Percentage of participants
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 2 N=12 ADA Gene Transfer Into Hematopoietic Stem/Progenitor Cells for the Treatment of ADA-SCID
Immunologic Deficiency Syndromes
Primary: Survival — 12 Participants
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=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 3 N=1,695 Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)
HIV Infection
Primary: New or Recurrent Disease Progression Events, as Defined, or Death. — 110; 119 Participants — p=0.47
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=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 2 N=10 Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Multiple Myeloma · Plasma Cell Neoplasm
Primary: Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One…