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=27 CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Primary Immunodeficiency
Primary: Occurrence of All Treatment-emergent Adverse Events (TEAEs) — 8; 19; 22; 155 events
Phase 2 N=79 Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
HIV · HIV Infections
Primary: Percentage of Participants With ≥1 Adverse Events (AEs) — 91 Percentage of Participants
Phase 3 N=12 An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Primary Immunodeficiency Disease
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs — 12; 3; 12 Participants
Phase 3 N=599 Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
HIV-1 Infection
Primary: Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 — 88.9; 88.3 Percentage of participants
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=22 A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Primary Immunodeficiency
Primary: AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin…
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=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 4 N=33 A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Primary Immunodeficiency
Primary: Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ) — 167045.65…
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=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=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 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 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