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
Showing 1 to 10 of 11 diseases
| 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 | NCT02638207 (ClinicalTrials.gov) | September 27, 2017 | 16/12/2015 | Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGamin Patients With Chronic I ... | Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of ... | Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy | Drug: NewGam | Octapharma | NULL | Completed | 18 Years | N/A | All | 142 | Phase 3 | Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark; ... |
| 2 | EUCTR2015-005443-14-BG (EUCTR) | 07/09/2017 | 30/05/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 3 | EUCTR2015-005443-14-SE (EUCTR) | 29/06/2017 | 07/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 4 | EUCTR2015-005443-14-DK (EUCTR) | 01/06/2017 | 06/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Canada;Czech Republic;Russian Federation;Sweden;Romania;Hungary;Ukraine;Denmark;Poland;Australia;Bulgaria;Germany Canada;Czech Republic;Russian Federation;Sweden;Romania;Hungary;Ukraine;Denmark;Poland;Australia;Bul ... | ||
| 5 | EUCTR2015-005443-14-CZ (EUCTR) | 01/06/2017 | 12/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 6 | EUCTR2015-005443-14-PL (EUCTR) | 16/05/2017 | 13/05/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 7 | EUCTR2015-005443-14-HU (EUCTR) | 12/05/2017 | 07/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 8 | EUCTR2015-005443-14-DE (EUCTR) | 28/04/2017 | 05/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of ... | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;C ... | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: ... | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;G ... | ||
| 9 | EUCTR2009-017805-13-CZ (EUCTR) | 14/07/2011 | 22/04/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TW ... | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TW ... | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Clas ... | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name ... | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Bulgaria | ||
| 10 | EUCTR2009-017805-13-BG (EUCTR) | 27/01/2011 | 13/12/2010 | Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy. | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TW ... | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;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] Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Clas ... | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name ... | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2/3 | India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria |