Kedrion IVIG 10%
( DrugBank: - / KEGG DRUG: - )
1 disease
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
65 | 原発性免疫不全症候群 | 7 |
65. 原発性免疫不全症候群
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
Showing 1 to 7 of 7 trials
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 |
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1 | EUCTR2020-001496-32-PT (EUCTR) | 11/05/202120210511 | 11/08/202020200811 | 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) Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ... | 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 A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ... | 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] Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ... | 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 | NCT04944979 (ClinicalTrials.gov) | March 31, 202120210331 | 11/6/202120210611 | Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIgin Pediatric PID Patients ( ... | 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) A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ... | Primary Immunodeficiency Disease | Biological: Kedrion IVIG 10% | Kedrion S.p.A. | NULL | Recruiting | 2 Years | 16 Years | All | 30 | Phase 3 | Hungary;Italy;Slovakia |
3 | EUCTR2020-001496-32-IT (EUCTR) | 21/12/202020201221 | 21/10/202020201021 | 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) Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ... | 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 A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ... | 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] Pediatric Patients Affected by Primary Immunodeficiency Disease MedDRA version: 20.0;Level: PT;Class ... | Product Name: KIg10 Product Code: [KIg10] INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Italy | ||
4 | EUCTR2020-001496-32-SK (EUCTR) | 01/10/202020201001 | 02/07/202020200702 | 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) Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ... | 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 A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ... | 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] Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ... | 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 | ||
5 | EUCTR2020-001496-32-HU (EUCTR) | 09/09/202020200909 | 02/07/202020200702 | 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) Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ... | 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 A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ... | 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] Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ... | 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 | ||
6 | NCT03961009 (ClinicalTrials.gov) | April 30, 201920190430 | 21/5/201920190521 | Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinet ... | Primary Immunodeficiency Disease | Biological: Kedrion IVIG 10% | Kedrion S.p.A. | NULL | Completed | 2 Years | 70 Years | All | 47 | Phase 3 | United States;Canada |
7 | NCT01581593 (ClinicalTrials.gov) | November 201220121100 | 16/4/201220120416 | Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) | Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID). Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerabili ... | Primary Immunodeficiency;Agammaglobulinemia;Hypogammaglobulinemia;Antibody Deficiency | Biological: Kedrion IVIG 10% | Kedrion S.p.A. | NULL | Active, not recruiting | 2 Years | 70 Years | Both | 50 | Phase 3 | United States;Canada |