65. 原発性免疫不全症候群
［臨床試験数：413，薬物数：581（DrugBank：97），標的遺伝子数：68，標的パスウェイ数：202］
Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04346108 (ClinicalTrials.gov) | August 11, 2020 | 10/4/2020 | Pharmacokinetics, Safety and Tolerability, and Efficacy Evaluation of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) | A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID) | Primary Immunodeficiency Diseases (PID) | Biological: Immune Globulin Intravenous (IGIV);Biological: Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%) | Baxalta now part of Shire | NULL | Recruiting | 2 Years | N/A | All | 16 | Phase 3 | Japan |
| 2 | 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) | 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 | Primary Immunodeficiency | Drug: IgPro20 | CSL Behring | NULL | Completed | 2 Years | N/A | All | 49 | Phase 4 | United States;Canada |
| 3 | EUCTR2015-003290-15-GB (EUCTR) | 12/05/2016 | 13/01/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Australia;Germany;United Kingdom;Sweden | ||
| 4 | NCT01218438 (ClinicalTrials.gov) | January 2013 | 8/10/2010 | Phase 2/3 Study of IGSC, 20% in PIDD | A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD) | Primary Immunodeficiency Diseases (PID) | Biological: Immune Globulin Intravenous (Human), 10% Solution;Drug: Immune Globulin Subcutaneous (Human), 20% Solution | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 86 | Phase 2;Phase 3 | United States;Canada |
| 5 | EUCTR2010-019459-23-BE (EUCTR) | 29/03/2012 | 14/02/2012 | CLINICAL STUDY OF THE EFFECTIVENESS AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 16.0;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2;Phase 3 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | ||
| 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 |
| 6 | NCT01461018 (ClinicalTrials.gov) | October 2011 | 24/10/2011 | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | Both | 22 | Phase 3 | Japan |
| 7 | EUCTR2010-019459-23-NL (EUCTR) | 24/08/2011 | 27/01/2011 | CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 16.0;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2;Phase 3 | Hungary;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 8 | NCT01412385 (ClinicalTrials.gov) | June 20, 2011 | 8/8/2011 | Immune Globulin Subcutaenous (Human), 20% | A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases (PID) | Biological: Immune Globulin Subcutaneous (Human), 20%;Biological: Immune Globulin Intravenous (Human), 10%;Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin) | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 55 | Phase 2;Phase 3 | Austria;Germany;Hungary;Sweden;United Kingdom |
| 9 | NCT01458171 (ClinicalTrials.gov) | April 2011 | 12/10/2011 | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency Disorder | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 23 | Phase 3 | Japan |
| 10 | EUCTR2010-019459-23-SE (EUCTR) | 23/03/2011 | 25/01/2011 | CLINICAL STUDY OF THE EFFECTIVENESS AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 16.0;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 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 |
| 11 | EUCTR2010-019459-23-DE (EUCTR) | 18/01/2011 | 28/07/2010 | CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 16.1;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneos, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 12 | EUCTR2010-019459-23-GB (EUCTR) | 21/12/2010 | 05/10/2010 | CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 14.1;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 13 | EUCTR2010-019459-23-HU (EUCTR) | 20/12/2010 | 20/10/2010 | CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 16.0;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 14 | EUCTR2010-019459-23-AT (EUCTR) | 05/11/2010 | 02/08/2010 | CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID | Primary Immunodeficiency Diseases MedDRA version: 14.1;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] | Trade Name: KIOVIG Product Name: KIOVIG Product Code: IGIV, 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: SUBCUVIA Product Name: SUBCUVIA Product Code: IGSC, 16% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Immune Globulin Subcutaneous, 20% Product Code: IGSC, 20% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 47 | Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 15 | NCT01199705 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | 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 | Primary Immune Deficiency | Biological: Immune Globulin Subcutaneous (Human) (SCIG) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 25 | Phase 3 | Japan |
| 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 |
| 16 | EUCTR2008-000830-30-SE (EUCTR) | 17/12/2008 | 03/11/2008 | 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 Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: normal human immunoglobulin G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 17 | 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. | 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) | 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] | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Spain;Poland;Romania;Germany;Switzerland;United Kingdom;Sweden | |||
| 18 | EUCTR2008-000830-30-FR (EUCTR) | 24/11/2008 | 21/10/2008 | 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 Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 19 | NCT00751621 (ClinicalTrials.gov) | August 2008 | 11/9/2008 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study) | 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) | Primary Immunodeficiency (PID) | Biological: IgPro20 | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 40 | Phase 3 | France;Germany;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |
| 20 | EUCTR2008-000830-30-DE (EUCTR) | 10/07/2008 | 09/06/2008 | 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 Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immuno deficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 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 |
| 21 | NCT00719680 (ClinicalTrials.gov) | June 2008 | 21/7/2008 | 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) | Primary Immune Deficiency | Biological: IgPro20 | CSL Behring | NULL | Completed | 2 Years | 75 Years | All | 21 | Phase 3 | United States |
| 22 | EUCTR2006-006522-25-GR (EUCTR) | 08/01/2008 | 04/06/2007 | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency | Trade Name: Vivaglobin Product Name: Vivaglobin INN or Proposed INN: immune globulin subcutaneous (human) | CSL Behring AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | United Kingdom;Germany;Belgium;Spain;Italy;Greece | |||
| 23 | EUCTR2006-006745-13-SE (EUCTR) | 19/09/2007 | 23/07/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 24 | NCT00542997 (ClinicalTrials.gov) | September 2007 | 11/10/2007 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy | A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Common Variable Immunodeficiency;X-linked Agammaglobulinemia;Autosomal Recessive Agammaglobulinemia | Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 51 | Phase 3 | France;Germany;Italy;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |
| 25 | EUCTR2006-006745-13-IT (EUCTR) | 30/08/2007 | 01/08/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - ND | A Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - ND | PID (Primary Immunodeficiency) MedDRA version: 6.1;Level: HLGT;Classification code 10021460 | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Immunoglobulins, normal human | CSL Behring AG (casa madre) | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 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 |
| 26 | EUCTR2006-006745-13-ES (EUCTR) | 27/08/2007 | 11/06/2007 | Estudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | Estudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | immunodeficencia primaria (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 27 | EUCTR2006-006745-13-GB (EUCTR) | 17/07/2007 | 15/05/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 3 | France;Poland;Spain;Germany;Italy;United Kingdom;Sweden | |||
| 28 | EUCTR2006-006745-13-DE (EUCTR) | 11/07/2007 | 21/03/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 29 | EUCTR2006-006745-13-FR (EUCTR) | 10/07/2007 | 04/06/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 30 | EUCTR2006-006522-25-ES (EUCTR) | 01/07/2007 | 03/03/2010 | Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)) | Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)) | Pacientes con inmunodeficiencia primaria como inmunodeficiencia variable común (CVID) o agammaglobulinemia vinculada al cromosoma X (XLA) de entre 1 y 70 años de edad.(Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years) MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency | Trade Name: Vivaglobin Product Name: Vivaglobin INN or Proposed INN: immune globulin subcutaneous (human) | CSL Behring AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | United Kingdom;Germany;Belgium;Spain;Italy;Greece | |||
| 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 |
| 31 | EUCTR2006-006522-25-BE (EUCTR) | 27/06/2007 | 17/04/2007 | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency | Trade Name: Vivaglobin Product Name: Vivaglobin INN or Proposed INN: immune globulin subcutaneous (human) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | United Kingdom;Germany;Belgium;Spain;Italy;Greece | |||
| 32 | EUCTR2006-006522-25-DE (EUCTR) | 01/02/2007 | 07/12/2006 | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) | Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency | Trade Name: Vivaglobin Product Name: Vivaglobin INN or Proposed INN: immune globulin subcutaneous (human) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | United Kingdom;Germany;Belgium;Spain;Italy;Greece | |||
| 33 | NCT00419341 (ClinicalTrials.gov) | November 2006 | 22/12/2006 | 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) | Primary Immune Deficiency | Biological: Human Normal Immunoglobulin for Subcutaneous Administration | CSL Behring | NULL | Completed | 2 Years | 75 Years | All | 49 | Phase 3 | United States |
| 34 | 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) | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency | 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 | CSL Behring | NULL | NA | Female: yes Male: yes | 22 | Japan | ||||
| 35 | 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) | 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 | 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] | 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 | CSL Behring LLC | NULL | NA | Female: yes Male: yes | 51 | Phase 4 | United States;Canada | |||
| 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 |
| 36 | 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) | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | 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 | CSL Behring | NULL | NA | Female: yes Male: yes | 23 | Japan | ||||
| 37 | 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 | 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 | CSL Behring | NULL | NA | Female: yes Male: yes | 25 | Japan | ||||
| 38 | 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) | 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] | Trade Name: Hizentra® Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring AG | NULL | NA | Female: yes Male: yes | 49 | Phase 3 | United States | |||
| 39 | EUCTR2014-003605-15-Outside-EU/EEA (EUCTR) | 26/02/2015 | 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) | 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] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring AG | NULL | NA | Female: yes Male: yes | 21 | United States |