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 | EUCTR2012-000792-16-DE (EUCTR) | 03/09/2012 | 10/05/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Octagam 5% Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Czech Republic;Hungary;Germany | |||
| 2 | EUCTR2012-000792-16-HU (EUCTR) | 14/06/2012 | 20/03/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) 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] | Trade Name: OCTAGAM 50 mg/ml oldatos infúzió Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Czech Republic;Hungary;Germany | |||
| 3 | EUCTR2012-000792-16-CZ (EUCTR) | 29/05/2012 | 27/03/2012 | Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases | CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” | primary immunodeficiency disease (PID) 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] | Trade Name: OCTAGAM Product Name: Octagam 5% Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Hungary;Czech Republic;Germany | |||
| 4 | EUCTR2007-002611-27-GB (EUCTR) | 19/02/2010 | 15/03/2010 | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Primary Immundeficiency Diseases (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Trade Name: Octagam 10% Product Name: Octagam 10% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Germany;United Kingdom | ||
| 5 | EUCTR2007-002611-27-FR (EUCTR) | 17/02/2010 | 26/11/2009 | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Primary Immunodeficiency Diseases (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 3 | France;Germany;United Kingdom | ||
| 6 | NCT00811174 (ClinicalTrials.gov) | January 2009 | 17/12/2008 | Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases | Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases | Immunologic Deficiency Syndromes | Drug: Octagam 10% | Octapharma | NULL | Terminated | 2 Years | 75 Years | All | 5 | Phase 3 | Austria |
| 7 | EUCTR2007-002611-27-DE (EUCTR) | 27/10/2008 | 14/12/2007 | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Primary Immundeficiency Diseases (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Trade Name: Octagam 10% Product Name: Octagam 10% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | France;Germany;United Kingdom |