8 completed, 1 withdrawn. 9 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 8, Withdrawn 1 |
Follow Primary Immunodeficiency: new trials by email Literature Review of Primary Immunodeficiency trials Research Report on Primary Immunodeficiency
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 Gamunex-C, IVIG-PEG - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 33 | 2020-09-02 | 2023-06-05 |
| Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump, IGSC 20% daily push versus 2 times per week pump - Primary Immunodeficiency | Phase 3 | Withdrawn | Grifols Therapeutics LLC | 2019-12-01 | 2020-04-10 | |
| Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency IGSC 20% - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 61 | 2016-06-01 | 2020-06-16 |
| 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 Octanorm 16.5% - Primary Immunodeficiency | Phase 3 | Completed | Octapharma | 27 | 2016-03-01 | 2020-10-27 |
| Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% Immune Globulin Intravenous, Prometic's Immune Globulin Intravenous 10% - Primary Immunodeficiency | Phase 3 | Completed | Prometic Biotherapeutics, Inc. | 82 | 2016-01-26 | 2021-11-05 |
| Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency IGIV-C 10%, IGSC 20% - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 53 | 2016-01-01 | 2019-10-04 |
| Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml Intravenous immunoglobulin infusion - Primary Immunodeficiency | Phase 3 | Completed | Prothya Biosolutions | 23 | 2013-12-01 | 2015-04-06 |
| Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) Kedrion IVIG 10% - Primary Immunodeficiency, Agammaglobulinemia | Phase 3 | Completed | Kedrion S.p.A. | 45 | 2012-11-12 | 2021-02-16 |
| Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. Gammaplex (Intravenous immunoglobulin) - Primary Immunodeficiency, Common Variable Hypogammaglobulinemia | Phase 3 | Completed | Bio Products Laboratory | 50 | 2006-01-01 | 2013-01-24 |
Primary Immunodeficiency Diseases (9) · Agammaglobulinemia (2) · Common Variable Immunodeficiency (1) · Hyper-IgM Immunodeficiency Syndrome (1) · Hypogammaglobulinemia, X-Linked (1) · Wiskott-Aldrich Syndrome (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Genetic Diseases, Inborn (9) · Immune System Diseases (9) · Immunologic Deficiency Syndromes (9) · Blood Protein Disorders (2) · Hematologic Diseases (2) · Hemic and Lymphatic Diseases (2) · Lymphatic Diseases (2) · Lymphoproliferative Disorders (2) · Blood Coagulation Disorders (1) · Blood Coagulation Disorders, Inherited (1) · Cytopenia (1) · Dysgammaglobulinemia (1) · Genetic Diseases, X-Linked (1) · Hemorrhagic Disorders (1)
gamma-Globulins (4) · Caprylates (2) · Chromatography (2) · Hizentra (1) · Immunoglobulins (1) · Immunoglobulins, Intravenous (1)
Grifols Therapeutics LLC (4) · Bio Products Laboratory (1) · Kedrion S.p.A. (1) · Octapharma (1) · Prometic Biotherapeutics, Inc. (1) · Prothya Biosolutions (1)
United States (7) · Canada (3) · Australia (1) · Czechia (1) · France (1) · Germany (1) · Hungary (1) · Netherlands (1) · Poland (1) · Spain (1) · Sweden (1) · United Kingdom (1)
F P Kroon, PhD, MD (1) · James Moy, MD (1) · Melvin Berger, MD (1) · Mirella Calcinai, MD (1)
2015 (1)