Human normal immunoglobulin (ivig) (DrugBank: Human normal immunoglobulin, IVIg)
2 diseasesID | Disease name (Link within this page) | Number of trials |
---|---|---|
50 | Dermatomyositis | 2 |
65 | Primary immunodeficiency | 4 |
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-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 | |||
2 | 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 | EUCTR2020-001496-32-SK (EUCTR) | 01/10/2020 | 02/07/2020 | Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID) | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study | Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;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] | Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Russian Federation;Italy | ||
2 | EUCTR2020-001496-32-HU (EUCTR) | 09/09/2020 | 02/07/2020 | Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID) | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study | Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;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] | Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Russian Federation;Italy | ||
3 | EUCTR2004-004465-15-HU (EUCTR) | 22/07/2005 | 11/05/2005 | A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) | A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) | primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome MedDRA version: 7.0;Level: HLT;Classification code 10036700 | Trade Name: Intratect Product Name: Intratect Product Code: BT681 Other descriptive name: human normal immunoglobulin (IVIg) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Hungary;Germany | |||
4 | EUCTR2004-004465-15-DE (EUCTR) | 05/04/2005 | 04/02/2005 | A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) | A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) | primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome MedDRA version: 7.0;Level: HLT;Classification code 10036700 | Product Name: Intratect Product Code: BT681 Other descriptive name: human normal immunoglobulin (IVIg) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Hungary;Germany |