Gammanorm ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 1 |
| 65 | 原発性免疫不全症候群 | 4 |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 167 / 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
| 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 | EUCTR2017-002024-24-DK (EUCTR) | 08/09/2017 | 19/06/2017 | Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy | Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy | Chronic inflammatory demyelinating polyneuroapthy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gammanorm Product Name: Gammanorm INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Trade Name: Hizentra Product Name: Hizentra INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Trade Name: Subcuvia Product Name: Subcuvia INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G | Aarhus Unversity Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Denmark |
65. 原発性免疫不全症候群
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 | NCT02503293 (ClinicalTrials.gov) | July 29, 2015 | 1/7/2015 | A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push | A Randomised, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push | Primary Immunodeficiency | Device: Chrono Super PID then Generic Syringe-Gammanorm;Device: Generic Syringe then Chrono Super PID-Gammanorm | Octapharma | NULL | Completed | 18 Years | N/A | All | 30 | Phase 4 | Australia;Germany;Italy;United Kingdom |
| 2 | EUCTR2014-003746-27-GB (EUCTR) | 16/04/2015 | 14/01/2015 | A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using an infusion pump or syringe | A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push - Gammanorm in immunodeficient patients: quality of life using infusion by pump or rapid push | immunodeficiency syndrome MedDRA version: 19.0;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Gammanorm 165 mg/mL | Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3;Phase 4 | Australia;Germany;United Kingdom | ||
| 3 | EUCTR2014-003746-27-DE (EUCTR) | 15/04/2015 | 01/12/2014 | A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using an infusion pump or syringe | A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push - Gammanorm in immunodeficient patients: quality of life using infusion by pump or rapid push | immunodeficiency syndrome MedDRA version: 19.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Gammanorm 165 mg/mL | Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3;Phase 4 | Australia;Germany;Italy;United Kingdom | ||
| 4 | NCT02180763 (ClinicalTrials.gov) | April 2014 | 23/6/2014 | Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps | A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push. | Primary Immunodeficiency (PID) | Biological: Gammanorm | Octapharma | NULL | Completed | 18 Years | N/A | All | 31 | Phase 4 | France |