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 | EUCTR2020-004006-54-DE (EUCTR) | 23/06/2021 | 08/03/2021 | Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) | Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) | Chronic inflammatory demyelinatingpolyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIVV020 Other descriptive name: BIVV020 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Poland;Netherlands;Germany;Italy | ||
| 2 | EUCTR2020-004006-54-PL (EUCTR) | 29/04/2021 | 31/03/2021 | Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) | Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) | Chronic inflammatory demyelinatingpolyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR445088 (formerly BIVV020) Other descriptive name: BIVV020 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Poland;Germany;Netherlands;Italy | ||
| 3 | NCT04658472 (ClinicalTrials.gov) | April 28, 2021 | 1/12/2020 | Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | A Phase 2, Multicenter, Open-label, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Drug: BIVV020/SAR445088 | Bioverativ, a Sanofi company | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 2 | United States;Canada;China;France;Germany;Italy;Netherlands;Poland;Serbia;Spain |
| 4 | EUCTR2020-004006-54-NL (EUCTR) | 15/04/2021 | 19/01/2021 | Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) | Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) | Chronic inflammatory demyelinatingpolyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIVV020 INN or Proposed INN: BIVV020 Other descriptive name: BIVV020 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Poland;Germany;Netherlands;Italy | ||
| 5 | EUCTR2020-004006-54-IT (EUCTR) | 14/04/2021 | 08/06/2021 | Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) | A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) - NA | Chronic inflammatory demyelinating polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIVV020 Product Code: [BIVV020] Other descriptive name: BIVV020 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;China;Italy | ||
| 6 | EUCTR2020-004006-54-FR (EUCTR) | 09/03/2021 | 23/12/2020 | Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) | Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) | Chronic inflammatory demyelinatingpolyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIVV020 Other descriptive name: BIVV020 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Netherlands |