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

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001698-10-NL
(EUCTR)
06/05/202119/03/2021Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Israel;Chile;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;New Zealand;Japan;Sweden
2EUCTR2019-001698-10-CY
(EUCTR)
24/09/202011/09/2020Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Latvia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
3EUCTR2019-001698-10-GR
(EUCTR)
17/07/202011/06/2020Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Greece;Spain;Ireland;Turkey;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;Japan;New Zealand;Sweden
4EUCTR2019-001698-10-SE
(EUCTR)
13/05/202024/02/2020Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Greece;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;New Zealand;Sweden
5EUCTR2019-001698-10-DE
(EUCTR)
29/03/202024/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Greece;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;New Zealand;Sweden
6EUCTR2019-001698-10-PT
(EUCTR)
19/03/202018/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Spain;Ireland;Chile;Switzerland;Italy;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden;Israel;France;Estonia;Greece;Canada
7EUCTR2019-001698-10-GB
(EUCTR)
06/03/202018/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
8EUCTR2019-001698-10-IT
(EUCTR)
27/02/202003/12/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Latvia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
9EUCTR2019-001698-10-ES
(EUCTR)
14/02/202002/12/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: Inoserten
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;Latvia;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;New Zealand;Japan