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 : 167 / 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04929236 (ClinicalTrials.gov) | August 1, 2022 | 11/6/2021 | Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients | Multicenter, Prospective, Double-Blinded, Parallel Group, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients | Pediatric Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Panzyga | Octapharma | NULL | Not yet recruiting | 2 Years | 17 Years | All | 30 | Phase 3 | NULL |
| 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | ||
| 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | ||
| 4 | NCT03166527 (ClinicalTrials.gov) | June 1, 2017 | 8/5/2017 | Panzyga in CIDP Administered at Different Infusion Rates | Prospective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion Rates | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Drug: Immune Globulin 10% Intravenous Solution | Vera Bril | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 3 | Canada |
| 5 | 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden | ||
| 6 | 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | ||
| 7 | 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | ||
| 8 | 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | ||
| 9 | 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 three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | 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] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | 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 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden |