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 Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | NCT05584631 (ClinicalTrials.gov) | October 18, 2022 | 10/10/2022 | IVIG vs SCIG in CIDP | The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration | CIDP;Immunoglobulin Deficiency;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Intravenous immune globulin G;Drug: Subcutaneous immune globulin G | Rutgers, The State University of New Jersey | NULL | Recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | United States |
| 2 | EUCTR2021-003302-50-IT (EUCTR) | 17/02/2022 | 26/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus type b vaccine (conjugated) Product Code: [.] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Intratect Product Name: Human normal immunoglobulin (IVIg) Product Code: [-] INN or Proposed INN: Human normal immunoglobulin (IVIg) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Menjugate Product Name: Group C meningococcal conjugate vaccine Product Code: [J07AH07] INN or Proposed INN: Group C meningococcal conjugate vaccine Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE Trade Name: Prevenar 13 sospensione per iniezione Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) Product Code: [NA] INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | EUCTR2013-005558-31-DE (EUCTR) | 10/08/2016 | 08/07/2016 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | 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 10% immunoglobulin for intravenous administrationn 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 | 30 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2015-000828-28-NL (EUCTR) | 26/07/2016 | 30/11/2015 | Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed. | Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne | Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hyqvia Product Name: Hyqvia | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 8 | EUCTR2015-003453-18-DK (EUCTR) | 25/11/2015 | 23/09/2015 | Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor Neuropathy | A Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy | Multifocal Motor Neuropathy (MMN) MedDRA version: 18.1;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: HyQvia Product Name: HyQvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Subcuvia Product Name: Subcuvia INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Rigshospitalet | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Denmark | ||
| 9 | EUCTR2013-005558-31-FR (EUCTR) | 23/07/2015 | 26/06/2015 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | 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 10% immunoglobulin for intravenous administrationn 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 | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 10 | EUCTR2011-003448-28-PL (EUCTR) | 07/07/2015 | 06/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 11 | EUCTR2011-003448-28-EE (EUCTR) | 11/06/2015 | 14/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 12 | EUCTR2011-003448-28-LT (EUCTR) | 09/06/2015 | 21/04/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 13 | 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 | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom;Italy | ||
| 14 | EUCTR2013-004157-24-CZ (EUCTR) | 12/03/2015 | 24/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 15 | NCT02414490 (ClinicalTrials.gov) | March 2015 | 13/3/2015 | IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements | Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER) | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Intravenous Immunoglobulin | University of Minnesota | BriovaRx Infusion Services;CSL Behring | Completed | 18 Years | 85 Years | All | 30 | United States | |
| 16 | EUCTR2013-005558-31-ES (EUCTR) | 18/02/2015 | 16/12/2014 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.1;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 10% immunoglobulin for intravenous administrationn 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 | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 17 | NCT02372149 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | IVIg for Demyelination in Diabetes Mellitus | Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study | Peripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chloride | University of Toronto | University Health Network, Toronto | Recruiting | 18 Years | N/A | Both | 25 | Phase 4 | Canada |
| 18 | EUCTR2013-005558-31-GB (EUCTR) | 08/01/2015 | 19/11/2014 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 20.0;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 10% 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 | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 19 | 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 | ||
| 20 | EUCTR2013-004157-24-NL (EUCTR) | 02/12/2014 | 20/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan | ||
| 21 | EUCTR2013-005557-73-GB (EUCTR) | 21/10/2014 | 15/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 20.0;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: 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 22 | EUCTR2013-004157-24-IT (EUCTR) | 01/10/2014 | 21/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy | ||
| 23 | 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 | ||
| 24 | 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 | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy | ||
| 25 | JPRN-JapicCTI-142472 | 04/8/2014 | 13/03/2014 | Phase 3 study of GGS in multifocal motor neuropathy (MMN) | Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study) | Multifocal motor neuropathy (MMN) | Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of the intervention : - Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Teijin Pharma Limited | NULL | complete | 20 | 74 | BOTH | 5 | Phase 3 | Japan |
| 26 | EUCTR2013-004157-24-DE (EUCTR) | 05/06/2014 | 25/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 27 | EUCTR2013-004157-24-GB (EUCTR) | 30/04/2014 | 18/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan;United Kingdom | ||
| 28 | EUCTR2013-004157-24-ES (EUCTR) | 23/04/2014 | 27/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan | ||
| 29 | EUCTR2013-004157-24-FI (EUCTR) | 04/04/2014 | 19/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 30 | JPRN-JapicCTI-142471 | 10/3/2014 | 13/03/2014 | Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) | Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study) | Chronic inflammatory demyelinating polyneuropathy(CIDP) | Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of the intervention : - Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Teijin Pharma Limited | NULL | complete | 20 | 74 | BOTH | 30 | Phase 3 | Japan |
| 31 | EUCTR2013-004988-32-NL (EUCTR) | 22/01/2014 | 20/01/2014 | Pharmacokinetics of IVIg treatment in patients with CIDP | Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 | Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kiovig Product Name: Kiovig | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 32 | 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 |
| 33 | EUCTR2012-001995-12-GB (EUCTR) | 01/08/2013 | 03/06/2013 | 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: 18.0;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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Italy;United Kingdom | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | EUCTR2013-001428-20-DK (EUCTR) | 06/06/2013 | 06/06/2013 | Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy | Randomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 16.0;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 normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Privigen INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 37 | EUCTR2011-003448-28-BE (EUCTR) | 27/09/2012 | 02/04/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 38 | EUCTR2011-003448-28-IT (EUCTR) | 23/08/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 39 | EUCTR2011-003448-28-GB (EUCTR) | 23/05/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 40 | EUCTR2011-003448-28-AT (EUCTR) | 18/05/2012 | 16/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 41 | EUCTR2011-003448-28-NL (EUCTR) | 11/05/2012 | 14/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 42 | EUCTR2011-003448-28-CZ (EUCTR) | 09/05/2012 | 23/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 43 | EUCTR2011-003448-28-ES (EUCTR) | 24/04/2012 | 29/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 44 | EUCTR2011-003448-28-DE (EUCTR) | 20/04/2012 | 31/01/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 45 | EUCTR2011-003448-28-FI (EUCTR) | 05/04/2012 | 05/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 46 | EUCTR2009-017672-24-FI (EUCTR) | 30/11/2010 | 10/09/2010 | This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP). | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen® INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Finland | |||
| 47 | EUCTR2009-017672-24-BE (EUCTR) | 13/09/2010 | 07/07/2010 | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 13.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Privigen® INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Finland;Belgium | ||
| 48 | EUCTR2009-013841-27-DK (EUCTR) | 17/12/2009 | 27/10/2009 | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | Multifocal motor neuropathy MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: IGIV, 10% Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Denmark | |||
| 49 | EUCTR2007-000710-37-GB (EUCTR) | 10/04/2008 | 15/02/2008 | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) | Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening. MedDRA version: 9.1;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: Vivaglobin Product Name: Vivaglobin Other descriptive name: IMMUNOGLOBULIN G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;Italy;United Kingdom | ||
| 50 | EUCTR2007-000710-37-DE (EUCTR) | 10/12/2007 | 10/09/2007 | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) | Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening. MedDRA version: 9.1;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: Vivaglobin Product Name: Vivaglobin Other descriptive name: IMMUNOGLOBULIN G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | United Kingdom;Germany;Italy | |||
| 51 | EUCTR2005-001136-76-IT (EUCTR) | 09/07/2007 | 07/09/2007 | Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP | Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;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: IGVENA*FL 200ML 10G+SET INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm. | KEDRION | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 52 | NCT01349270 (ClinicalTrials.gov) | June 2004 | 5/5/2011 | Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg | Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up | Demyelinating Polyneuropathy | Drug: Immunoglobulin perfusion;Drug: Prednisone | Centre Hospitalier Universitaire de Saint Etienne | Laboratoire français de Fractionnement et de Biotechnologies | Completed | 18 Years | 80 Years | Both | 40 | Phase 3 | France |
| 53 | NCT00001287 (ClinicalTrials.gov) | December 1990 | 3/11/1999 | Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Demyelinating Diseases;Paraproteinemias | Drug: intravenous immunoglobulin (IVIg) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 60 | Phase 2 | United States |