65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
| 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 | 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) | Primary Immunodeficiency Disorders | Drug: Hizentra | University of South Florida | NULL | Recruiting | 1 Year | 75 Years | Both | 50 | N/A | United States |
| 2 | 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 | Not Recruiting | Female: yes Male: yes | 28 | Phase 4 | Greece;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2006-006522-25-GB (EUCTR) | 10/09/2007 | 28/03/2007 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Greece;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2006-006522-25-IT (EUCTR) | 13/08/2007 | 31/07/2007 | A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND | A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND | Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years. MedDRA version: 6.1;Level: PT;Classification code 10057863 | Trade Name: Vivaglobin INN or Proposed INN: immunglobulin (human) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | United Kingdom;Germany;Belgium;Spain;Italy;Greece | |||
| 5 | 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 | Not Recruiting | Female: yes Male: yes | 28 | Phase 4 | Greece;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 6 | 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 | |||
| 7 | NCT00520494 (ClinicalTrials.gov) | March 2007 | 23/8/2007 | Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency | A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID) | Common Variable Immunodeficiency;Agammaglobulinemia | Drug: Vivaglobin | CSL Behring | NULL | Completed | 1 Year | 70 Years | All | 18 | Phase 4 | Canada;Germany;Italy;Spain;Belgium |
| 8 | 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 |