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

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001427-40-SE
(EUCTR)
26/04/202228/01/2022Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyAn Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;United States;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Germany;New Zealand;Sweden
2EUCTR2021-001427-40-ES
(EUCTR)
12/04/202225/01/2022Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyAn Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy 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: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: Eplontersen
Other descriptive name: ION-682884
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Germany;New Zealand;Sweden
3EUCTR2019-001698-10-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
4EUCTR2019-001698-10-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