65. Primary immunodeficiency Clinical trials / Disease details
Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 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 | 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 | EUCTR2016-001631-12-Outside-EU/EEA (EUCTR) | 30/01/2017 | The pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency | Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese 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: Privigen Product Name: Privigen; immunoglobulin intravenous (human) Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring KK | NULL | NA | Female: yes Male: yes | 10 | Phase 3 | Japan | |||
| 5 | 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 | ||||
| 6 | 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 |