28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
| 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 | EUCTR2020-000713-32-CZ (EUCTR) | 19/09/2022 | 07/02/2022 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | Russian Federation;United States;Czechia;Japan;Korea, Democratic People's Republic of;United Kingdom;Switzerland;Spain;Greece;Canada;Czech Republic;Austria;Netherlands;Belgium;Brazil;Poland;Italy;Israel;Australia;France;Germany | ||
| 2 | EUCTR2020-000713-32-AT (EUCTR) | 24/01/2022 | 16/07/2021 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan | ||
| 3 | EUCTR2019-004254-28-AT (EUCTR) | 24/01/2022 | 16/07/2021 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Brazil;Australia;Netherlands;Germany;Japan | ||
| 4 | EUCTR2019-004254-28-PL (EUCTR) | 23/02/2021 | 22/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | Canada;Poland;Belgium;United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Australia;Germany;Japan | ||
| 5 | EUCTR2020-000713-32-PL (EUCTR) | 17/02/2021 | 19/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Japan | ||
| 6 | EUCTR2019-004254-28-BE (EUCTR) | 04/01/2021 | 05/11/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 7 | EUCTR2019-004254-28-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan | ||
| 8 | EUCTR2020-000713-32-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan | ||
| 9 | EUCTR2020-000713-32-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Czechia;Greece;Spain;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan | ||
| 10 | EUCTR2019-004254-28-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan |