Human normal immunoglobulin for intravenous administration (DrugBank: Human normal immunoglobulin)
3 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 | 8 |
| 51 | 全身性強皮症 | 2 |
| 65 | 原発性免疫不全症候群 | 7 |
| 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 | EUCTR2013-005557-73-DE (EUCTR) | 10/08/2016 | 08/07/2016 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IQYMUNE Product Name: human normal immunoglobulin for intravenous administration Product Code: I10 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2012-001995-12-IT (EUCTR) | 19/05/2015 | 13/03/2013 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 15.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom;Italy | ||
| 3 | EUCTR2013-005557-73-ES (EUCTR) | 03/12/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 4 | EUCTR2013-005557-73-IT (EUCTR) | 30/09/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy | ||
| 5 | EUCTR2013-005557-73-FR (EUCTR) | 24/09/2014 | 26/06/2015 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom | |||
| 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 |
| 6 | NCT01951924 (ClinicalTrials.gov) | December 2013 | 20/9/2013 | LIME Study (LFB IVIg MMN Efficacy Study) | A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy | Motor Neuron Disease | Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL) | Laboratoire français de Fractionnement et de Biotechnologies | TFS Trial Form Support | Completed | 18 Years | 80 Years | Both | 23 | Phase 3 | France;Italy;Spain;United Kingdom |
| 7 | EUCTR2012-001995-12-ES (EUCTR) | 12/07/2013 | 12/07/2013 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom | ||
| 8 | EUCTR2012-001995-12-FR (EUCTR) | 03/07/2013 | 04/04/2014 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom |
| 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 | EUCTR2018-003149-41-DE (EUCTR) | 16/07/2019 | 20/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2018-003149-41-GB (EUCTR) | 15/05/2019 | 30/07/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom |
| 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 | EUCTR2015-003652-52-GB (EUCTR) | 02/02/2017 | 08/08/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;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: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Russian Federation;Germany;United Kingdom | ||
| 2 | NCT02810444 (ClinicalTrials.gov) | October 2016 | 15/6/2016 | Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID | An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID) | Immunodeficiency Primary | Biological: BT595 | Biotest | Syneos Health | Completed | 2 Years | 75 Years | All | 82 | Phase 3 | United States;Germany;Hungary;Russian Federation;Spain |
| 3 | EUCTR2015-003652-52-DE (EUCTR) | 29/09/2016 | 18/05/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | Replacement therapy in patients with primary immunodeficiency disease (PID) 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: IgG Next Generation Product Code: BT595 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;Germany;United Kingdom | ||
| 4 | EUCTR2015-003652-52-ES (EUCTR) | 19/09/2016 | 15/07/2016 | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) | Replacement therapy in patients with primary immunodeficiency disease (PID) MedDRA version: 19.0;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] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Spain;Russian Federation;Germany;United Kingdom | |||
| 5 | EUCTR2007-001410-17-FR (EUCTR) | 31/05/2007 | 13/04/2007 | LONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS | LONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS | Primary Immunodeficiency MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: Human normal immunoglobulin for intravenous administration Product Code: IGNG INN or Proposed INN: Human normal immunoglobulin for intravenous administration | LFB SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 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 |
| 6 | 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 | |||
| 7 | 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 |