65. Primary immunodeficiency Clinical trials / Disease details
Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
Showing 1 to 9 of 9 diseases
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT03033745 (ClinicalTrials.gov) | February 1, 2017 | 23/1/2017 | Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary ... | An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameter ... | Primary Immunodeficiency | Drug: IgPro20 | CSL Behring | NULL | Completed | 2 Years | N/A | All | 49 | Phase 4 | United States;Canada |
2 | NCT01354587 (ClinicalTrials.gov) | October 2010 | 18/3/2011 | Evaluation of Efficacy and Tolerability of Hizentra® | Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product) Evaluation of Efficacy and Tolerability of Hizentra®in Subjects Transitioning From Vivaglobin® (16% ... | Primary Immunodeficiency Disorders | Drug: Hizentra | University of South Florida | NULL | Recruiting | 1 Year | 75 Years | Both | 50 | N/A | United States |
3 | EUCTR2008-000830-30-GB (EUCTR) | 10/12/2008 | 20/01/2009 | Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneous (Human), IgPro20. Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneo ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | PID (Primary Immune Deficiency) MedDRA version: 13.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PID (Primary Immune Deficiency) MedDRA version: 13.1;Level: PT;Classification code 10064859;Term: Pr ... | Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;Spain;Poland;Romania;Germany;Switzerland;United Kingdom;Sweden | ||
4 | EUCTR2014-003605-15-Outside-EU/EEA (EUCTR) | 26/02/2015 | Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) ... | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID) A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutane ... | Primary Immune Deficiency (PID) MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Immune Deficiency (PID) MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Pr ... | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN N ... | CSL Behring AG | NULL | NA | Female: yes Male: yes | 21 | United States | ||||
5 | EUCTR2014-003609-14-Outside-EU/EEA (EUCTR) | 05/01/2015 | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan ... | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Sub ... | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN N ... | CSL Behring | NULL | NA | Female: yes Male: yes | 23 | Japan | ||||
6 | EUCTR2014-003409-13-Outside-EU/EEA (EUCTR) | 05/01/2015 | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects with Primary Immunodeficiency (Japan Study) Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects ... | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) Ig ... | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: Human Normal Immunoglobulin Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: Human N ... | CSL Behring | NULL | NA | Female: yes Male: yes | 22 | Japan | ||||
7 | EUCTR2014-003607-30-Outside-EU/EEA (EUCTR) | 26/02/2015 | Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy | A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID) A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Ph ... | Primary Immune Deficiency MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Immune Deficiency MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary ... | Trade Name: Hizentra® Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Hizentra® Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Imm ... | CSL Behring AG | NULL | NA | Female: yes Male: yes | 49 | Phase 3 | United States | |||
8 | EUCTR2014-003608-61-Outside-EU/EEA (EUCTR) | 05/01/2015 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcu ... | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN N ... | CSL Behring | NULL | NA | Female: yes Male: yes | 25 | Japan | ||||
9 | EUCTR2016-003799-33-Outside-EU/EEA (EUCTR) | 30/01/2017 | Safety and tolerability of higher infusion parameters of IgPro20 (Hizentra) in subjects with primary immunodeficiency (PID) Safety and tolerability of higher infusion parameters of IgPro20 (Hizentra) in subjects with primary ... | An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameters of immune globulin subcutaneous (human), 20% liquid (Hizentra®) in subjects with primary immunodeficiency An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameter ... | Primary immunodeficiency MedDRA version: 19.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary immunodeficiency MedDRA version: 19.1;Level: PT;Classification code 10064859;Term: Primary i ... | Trade Name: Hizentra Product Name: Hizentra; human normal immunoglobulin (subcutaneous) Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Hizentra Product Name: Hizentra; human normal immunoglobulin(subcutaneous) Product Code: I ... | CSL Behring LLC | NULL | NA | Female: yes Male: yes | 51 | Phase 4 | United States;Canada |