65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | EUCTR2016-003438-26-HU (EUCTR) | 28/08/2019 | 20/06/2019 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Czech Republic;Hungary;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 2 | EUCTR2016-003438-26-GR (EUCTR) | 13/11/2017 | 11/10/2017 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 3 | NCT03116347 (ClinicalTrials.gov) | June 13, 2017 | 12/4/2017 | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases (PID) | Biological: HYQVIA;Biological: KIOVIG;Biological: Cuvitru | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Completed | 2 Years | 17 Years | All | 42 | Phase 4 | Czechia;Denmark;France;Greece;Slovakia;Sweden;United Kingdom |
| 4 | EUCTR2016-003438-26-CZ (EUCTR) | 18/05/2017 | 27/01/2017 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 5 | EUCTR2016-003438-26-DK (EUCTR) | 08/05/2017 | 19/01/2017 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 6 | EUCTR2016-003438-26-FR (EUCTR) | 18/04/2017 | 21/03/2017 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) 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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 7 | EUCTR2016-003438-26-SE (EUCTR) | 04/04/2017 | 08/11/2016 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 8 | EUCTR2016-003438-26-GB (EUCTR) | 14/02/2017 | 01/11/2016 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) MedDRA version: 20.0;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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | France;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden | ||
| 9 | EUCTR2012-000481-38-GB (EUCTR) | 28/06/2012 | 26/04/2012 | Assessment of the safety of Immunoglobulin and recombinant human hylaluronidase in the treatment of patients with primary immunodeficiency | Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Study in Europe - Tolerability and Safety of IG, 10% with rHuPH20 in PIDD | Primary Immunodeficiency Diseases MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Belgium;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | |||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 | |||
| 16 | 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 | |||
| 17 | EUCTR2016-003438-26-SK (EUCTR) | 01/02/2017 | Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study. | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases | Primary Immunodeficiency Disease (PIDD) 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: HyQvia 100 mg/ml solution for infusion for subcutaneous use Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: KIOVIG INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection Product Name: Cuvitru INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Baxalta US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden |