HUMAN IMMUNOGLOBULIN G ( DrugBank: Human immunoglobulin G )
4 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 | 2 |
| 50 | 皮膚筋炎／多発性筋炎 | 5 |
| 63 | 特発性血小板減少性紫斑病 | 2 |
| 65 | 原発性免疫不全症候群 | 1 |
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 | EUCTR2018-003592-34-DK (EUCTR) | 02/08/2019 | 14/03/2019 | Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathy | Subcutaneous immunoglobulin in de-novo CIDP(Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy) - SIDEC | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10064135;Term: Polyneuropathy chronic;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra Product Name: Hizentra INN or Proposed INN: Human Immunoglobulin G Other descriptive name: HUMAN IMMUNOGLOBULIN G Trade Name: Privigen Product Name: Privigen INN or Proposed INN: Human Immunoglobulin G Other descriptive name: HUMAN IMMUNOGLOBULIN G | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Denmark | ||
| 2 | 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 |
50. 皮膚筋炎／多発性筋炎
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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 | EUCTR2018-003171-35-DE (EUCTR) | 20/01/2020 | 18/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Australia;Germany;Japan | ||
| 2 | EUCTR2018-003171-35-ES (EUCTR) | 14/11/2019 | 29/11/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan | ||
| 3 | EUCTR2018-003171-35-IT (EUCTR) | 21/10/2019 | 22/01/2021 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - NA | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: [IgPro20] INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan | ||
| 4 | NCT04044690 (ClinicalTrials.gov) | October 21, 2019 | 1/8/2019 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study | Dermatomyositis | Drug: human immunoglobulin G;Drug: Placebo | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | United States;Australia;Belgium;France;Germany;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom |
| 5 | EUCTR2018-003171-35-FR (EUCTR) | 24/09/2019 | 11/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland |
63. 特発性血小板減少性紫斑病
臨床試験数 : 363 / 薬物数 : 212 - (DrugBank : 43) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 138
| 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 | EUCTR2005-003552-35-DE (EUCTR) | 28/03/2006 | 13/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Czech Republic;Germany;France | |||
| 2 | EUCTR2005-003552-35-AT (EUCTR) | 20/02/2006 | 16/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | France;Czech Republic;Austria;Germany |
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 | EUCTR2008-000830-30-SE (EUCTR) | 17/12/2008 | 03/11/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: normal human immunoglobulin G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden |