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：145，薬物数：139（DrugBank：23），標的遺伝子数：12，標的パスウェイ数：21］
Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 |