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 | NCT01313507 (ClinicalTrials.gov) | May 2011 | 9/3/2011 | High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) | Clinical Study to Evaluate the Safety and Tolerability of Immunoglobulin Intravenous (Human) 10% (NewGam) Administered at High Infusion Rates to Patients With Primary Immunodeficiency Diseases (Extension of Study NGAM-01) | Primary Immunodeficiency Disease | Biological: NewGam | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 21 | Phase 3 | United States |
| 2 | EUCTR2009-011434-10-DE (EUCTR) | 02/03/2010 | 27/10/2009 | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | Primary immunodeficiency diseases MedDRA version: 12.0;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency MedDRA version: 12.0;Classification code 10049485;Term: Bruton's agammaglobulinemia | Product Name: NewGam Product Code: NewGam INN or Proposed INN: immunoglobulin G Other descriptive name: NewGam | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 3 | NCT01012323 (ClinicalTrials.gov) | January 2010 | 11/11/2009 | A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases | Clinical Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Patients With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases | Biological: NewGam | Octapharma | Premier Research Group plc | Completed | 2 Years | 75 Years | All | 51 | Phase 3 | United States |
| 4 | EUCTR2009-011434-10-Outside-EU/EEA (EUCTR) | 27/01/2012 | Study to evaluate the efficacy, metabolism and safety of human immune globulin in patients with primary immunodeficiency diseases. | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES | Primary immunodeficiency diseases MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NewGam Product Code: NewGam Other descriptive name: Immunoglobulin G | OCTAPHARMA AG | NULL | NA | Female: yes Male: yes | 51 | United States | ||||
| 5 | EUCTR2011-005015-82-Outside-EU/EEA (EUCTR) | 10/01/2012 | Study to evaluate the safety of human immune globulin in patients withprimary immunodeficiency diseases. | Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (extension of study NGAM 01) | primary immunodeficiency diseases MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NewGAM Product Code: NewGam Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | NA | Female: yes Male: yes | 20 | United States |