Human Transthyretin Antisense Oligonucleotide ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス15

28. 全身性アミロイドーシス


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-005115-13-ES
(EUCTR)
25/04/201819/02/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United Kingdom;New Zealand;Italy;Portugal;France;United States;Argentina;Brazil;Spain;Germany
2EUCTR2017-005115-13-PT
(EUCTR)
23/04/201806/03/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A 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.NULLNot RecruitingFemale: yes
Male: yes
164Phase 3France;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
3EUCTR2013-004561-13-ES
(EUCTR)
28/12/201530/10/2015Not availableAn 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
4EUCTR2013-004561-13-DE
(EUCTR)
22/09/201515/06/2015Not availableAn 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, IncNULLNot RecruitingFemale: yes
Male: yes
135Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
5EUCTR2013-004561-13-GB
(EUCTR)
23/07/201509/02/2015Not availableAn 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Germany;Italy;United Kingdom
6EUCTR2012-001831-30-BG
(EUCTR)
23/04/201523/02/2015A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2/3Portugal;France;United States;Mexico;Argentina;Brazil;Spain;Australia;Bulgaria;Germany;Italy;United Kingdom
7EUCTR2013-004561-13-PT
(EUCTR)
04/07/201407/05/2014Not availableAn 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, IncNULLNot RecruitingFemale: yes
Male: yes
135Phase 3United States;France;Portugal;Argentina;Spain;Brazil;Germany;United Kingdom;New Zealand;Italy
8EUCTR2012-001831-30-ES
(EUCTR)
25/04/201407/03/2014A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2;Phase 3United States;France;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;United Kingdom;Italy
9EUCTR2013-004561-13-FR
(EUCTR)
16/04/201417/06/2015Not availableAn 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, IncNULLNot RecruitingFemale: yes
Male: yes
195Phase 3United States;Portugal;France;Argentina;Spain;Brazil;Germany;United Kingdom;Italy
10EUCTR2012-001831-30-DE
(EUCTR)
22/08/201329/05/2013A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot 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): noPortugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
11EUCTR2012-001831-30-IT
(EUCTR)
04/07/201319/06/2013A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2;Phase 3France;United States;Portugal;Spain;Brazil;Bulgaria;Germany;United Kingdom;Italy
12EUCTR2012-001831-30-GB
(EUCTR)
22/04/201316/11/2012A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
13EUCTR2012-001831-30-PT
(EUCTR)
21/02/201320/11/2012A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA 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.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3France;United States;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
14EUCTR2017-005115-13-FR
(EUCTR)
27/02/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A 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.NULLNAFemale: yes
Male: yes
164Phase 3Portugal;United States;France;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
15EUCTR2017-005115-13-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.NULLNot 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): noPortugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom