Ig vena (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 50 | 皮膚筋炎／多発性筋炎 | 4 |
| 63 | 特発性血小板減少性紫斑病 | 2 |
| 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 | EUCTR2005-002463-88-HU (EUCTR) | 11/03/2010 | 01/10/2009 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy(Glucocorticosteroids associated with immunosuppresors) | Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 2 | EUCTR2005-002463-88-CZ (EUCTR) | 16/12/2009 | 05/10/2009 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy (Glucocorticosteroids associated with immunosuppressors) | Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglogulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Germany;Czech Republic;Italy;Austria | |||
| 3 | EUCTR2005-002463-88-DE (EUCTR) | 18/07/2006 | 28/12/2005 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors). | Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 4 | EUCTR2005-002463-88-AT (EUCTR) | 02/02/2006 | 17/01/2006 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors). | Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria |
| 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 | EUCTR2013-000961-36-IT (EUCTR) | 22/11/2013 | 21/08/2013 | See the full title | Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed | Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ig VENA 100 ml vial Product Name: Ig VENA | Kedrion SpA | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Italy | ||
| 2 | EUCTR2013-000961-36-DE (EUCTR) | 15/11/2013 | 05/08/2013 | See the full title | Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed | Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.1;Level: PT;Classification code 10054979;Term: Secondary immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 16.1;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set | Kedrion SpA | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Germany;Italy |