28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 261 / 薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
| 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 | EUCTR2017-005115-13-ES (EUCTR) | 25/04/2018 | 19/02/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United Kingdom;New Zealand;Italy;Portugal;France;United States;Argentina;Brazil;Spain;Germany | ||
| 2 | EUCTR2017-005115-13-PT (EUCTR) | 23/04/2018 | 06/03/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | France;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | ||
| 3 | EUCTR2013-004561-13-ES (EUCTR) | 28/12/2015 | 30/10/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 18.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | |||
| 4 | EUCTR2013-004561-13-DE (EUCTR) | 22/09/2015 | 15/06/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | ||
| 5 | EUCTR2013-004561-13-GB (EUCTR) | 23/07/2015 | 09/02/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 19.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2012-001831-30-BG (EUCTR) | 23/04/2015 | 23/02/2015 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 18.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2/3 | Portugal;France;United States;Mexico;Argentina;Brazil;Spain;Australia;Bulgaria;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2013-004561-13-PT (EUCTR) | 04/07/2014 | 07/05/2014 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | United States;France;Portugal;Argentina;Spain;Brazil;Germany;United Kingdom;New Zealand;Italy | ||
| 8 | EUCTR2012-001831-30-ES (EUCTR) | 25/04/2014 | 07/03/2014 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2;Phase 3 | United States;France;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2013-004561-13-FR (EUCTR) | 16/04/2014 | 17/06/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 18.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 3 | United States;Portugal;France;Argentina;Spain;Brazil;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2012-001831-30-DE (EUCTR) | 22/08/2013 | 29/05/2013 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 11 | EUCTR2012-001831-30-IT (EUCTR) | 04/07/2013 | 19/06/2013 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2;Phase 3 | France;United States;Portugal;Spain;Brazil;Bulgaria;Germany;United Kingdom;Italy | ||
| 12 | EUCTR2012-001831-30-GB (EUCTR) | 22/04/2013 | 16/11/2012 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 13 | EUCTR2012-001831-30-PT (EUCTR) | 21/02/2013 | 20/11/2012 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | France;United States;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 14 | EUCTR2017-005115-13-GB (EUCTR) | 06/03/2018 | A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | |||
| 15 | EUCTR2017-005115-13-FR (EUCTR) | 27/02/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 164 | Phase 3 | Portugal;United States;France;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom |