21 completed. 21 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 21 | Completed 21 |
Follow Primary Immunodeficiency Diseases: new trials by email Literature Review of Primary Immunodeficiency Diseases trials Research Report on Primary Immunodeficiency Diseases
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 |
|---|---|---|---|---|---|---|
| An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID) IgPro - Primary Immunodeficiency | Phase 4 | Completed | CSL Behring | 8 | 2025-07-15 | 2026-07-16 |
| Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab Garadacimab - Hereditary Angioedema | Phase 4 | Completed | CSL Behring | 18 | 2025-04-28 | 2026-07-23 |
| A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema Icatibant Injection (Icanticure®) - Bradykinin-mediated Angioedema, Hereditary Angioedema (HAE) | Phase 4 | Completed | Nang Kuang Pharmaceutical Co., Ltd. | 5 | 2024-09-27 | 2025-12-18 |
| Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age Trumenba - Meningococcal Vaccine | Phase 4 | Completed | Pfizer | 53 | 2021-08-18 | 2024-10-16 |
| A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency IGSC 20% - Primary Immunodeficiency | Phase 4 | Completed | Grifols Therapeutics LLC | 33 | 2020-11-24 | 2023-09-29 |
| Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest) Ruconest - Hereditary Angioedema | Phase 4 | Completed | Bernstein Clinical Research Center | 5 | 2018-08-14 | 2024-11-15 |
| A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions C1-esterase inhibitor [recombinant] (C1-INH-R) - CVI - Common Variable Immunodeficiency | Phase 4 | Completed | IMMUNOe Research Centers | 20 | 2018-06-13 | 2021-02-15 |
| Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects HYQVIA, KIOVIG, Cuvitru - Primary Immunodeficiency Diseases (PID) | Phase 4 | Completed | Baxalta now part of Shire | 42 | 2017-05-30 | 2023-01-11 |
| Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) IgPro20 - Primary Immunodeficiency | Phase 4 | Completed | CSL Behring | 49 | 2017-02-01 | 2020-03-25 |
| IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia IgHy10 - Primary Immunodeficiency | Phase 4 | Completed | University Hospital, Lille | 22 | 2016-11-11 | 2019-06-25 |
| Response of Individuals With Ataxia-Telangiectasia to Metformin and Pioglitazone Metformin, Pioglitazone - Ataxia-Telangiectasia | Phase 4 | Completed | NHS Tayside | 27 | 2016-09-29 | 2017-12-04 |
| Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules Subcutaneous Immune Globulin (Human) (Hizentra) - Primary Immune Deficiency, Secondary Immune Deficiency | Phase 4 | Completed | CSL Behring | 26 | 2016-03-15 | 2018-02-26 |
| A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push Chrono Super PID then Generic Syringe-Gammanorm, Generic Syringe then Chrono Super PID-Gammanorm - Primary Immunodeficiency | Phase 4 | Completed | Octapharma | 30 | 2015-07-29 | 2019-04-09 |
| Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps Gammanorm - Primary Immunodeficiency (PID) | Phase 4 | Completed | Octapharma | 31 | 2014-04-01 | 2018-09-05 |
| A Call Center During HAE Attacks (SOS HAE) phone to the call center - Hereditary Angioedema | Phase 4 | Completed | Assistance Publique - Hôpitaux de Paris | 200 | 2013-03-01 | 2016-12-13 |
| Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE Icatibant - Hereditary Angioedema | Phase 4 | Completed | Massachusetts General Hospital | 19 | 2011-12-01 | 2016-10-18 |
| Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency GAMUNEX-C - Primary Immunodeficiency | Phase 4 | Completed | Grifols Therapeutics LLC | 12 | 2011-11-01 | 2015-03-13 |
| A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency Gammaplex - Primary Immune Deficiency Disorders, Common Variable Immunodeficiency | Phase 4 | Completed | Bio Products Laboratory | 25 | 2011-03-01 | 2014-12-23 |
| A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE C1 inhibitor (human) [C1 INH] - Hereditary Angioedema | Phase 4 | Completed | Shire | 20 | 2009-08-31 | 2021-06-23 |
| Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects Flebogamma 5% DIF - Primary Immune Deficiency Disease | Phase 4 | Completed | Instituto Grifols, S.A. | 24 | 2008-05-01 | 2017-02-02 |
Showing 20 of 21. Sign in to see all of them.
Angioedemas, Hereditary (7) · Bruton type agammaglobulinemia (3) · Common Variable Immunodeficiency (3) · Hyper-IgM Immunodeficiency Syndrome (2) · Wiskott-Aldrich Syndrome (2) · Agammaglobulinemia (1) · Anemia, Sickle Cell (1) · Ataxia Telangiectasia (1) · Bacterial Infections (1) · Drug-Related Side Effects and Adverse Reactions (1) · Hereditary Complement Deficiency Diseases (1) · Immune System Diseases (1) · Immunologic Deficiency Syndromes (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (21) · Genetic Diseases, Inborn (21) · Immune System Diseases (20) · Immunologic Deficiency Syndromes (20) · Cardiovascular Diseases (8) · Vascular Diseases (8) · Angioedema (7) · Hereditary Complement Deficiency Diseases (7) · Hypersensitivity (7) · Hypersensitivity, Immediate (7) · Skin Diseases (7) · Skin Diseases, Vascular (7) · Skin and Connective Tissue Diseases (7) · Urticaria (7)
Hizentra (4) · gamma-Globulins (4) · Complement C1 Inhibitor Protein (2) · icatibant (2) · Caprylates (1) · Fluid Therapy (1) · MenB-FHbp vaccine (1) · Metformin (1) · Pioglitazone (1) · SERPING1 protein, human (1) · Vivaglobin (1) · conestat alfa (1)
CSL Behring (5) · Grifols Therapeutics LLC (2) · Octapharma (2) · Assistance Publique - Hôpitaux de Paris (1) · Baxalta now part of Shire (1) · Bernstein Clinical Research Center (1) · Bio Products Laboratory (1) · IMMUNOe Research Centers (1) · Instituto Grifols, S.A. (1) · Massachusetts General Hospital (1) · NHS Tayside (1) · Nang Kuang Pharmaceutical Co., Ltd. (1) · Pfizer (1) · Shire (1) · University Hospital, Lille (1)
United States (11) · Canada (4) · France (4) · Germany (3) · United Kingdom (3) · Czechia (2) · Italy (2) · Australia (1) · Chile (1) · Denmark (1) · Greece (1) · Hungary (1) · Israel (1) · Poland (1) · Slovakia (1)
Aleena Banerji, M.D. (1) · Boris Bienvenu, MD (1) · Elie Haddad, MD (1) · Eric Hachulla, MD, PhD (1) · Ewan Pearson, MD PhD (1) · Isaac Melamed, MD (1) · Jonathan Bernstein, MD (1) · Klaus Warnatz, MD (1) · Mark Ballow, MD (1) · Michael Borte, MD (1) · Tim J. Aldwinckle, MD (1)
PMID 21932110, PMID 27140403, PMID 27342758, PMID 29503044, PMID 29855752, PMID 31109849, PMID 33025378, PMID 33409867, PMID 33737935, PMID 36818468, PMID 39289739
2016 (3), 2015 (1), 2018 (1)