ISIS 420915 ( 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27

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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
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Inclusion_
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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 finishedFemale: yes
Male: yes
140Phase 3Cyprus;Korea, Democratic People's Republic of;Malaysia;Portugal;Greece;Austria;Latvia;Netherlands;Sweden;China;Ireland;Brazil;Chile;France;Colombia;Argentina;Japan;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Taiwan;Italy;Mexico;Israel;Australia;Germany;Estonia
10EUCTR2017-005115-13-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
11EUCTR2017-005115-13-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
12NCT02627820
(ClinicalTrials.gov)
January 201619/11/2015The Effect of an Antisense Oligonucleotide to Lower Transthyretin (TTR) Levels on the Progression of -Wild-type TTR Involving the HeartAn 18 Month Open Label Study Of The Tolerability And Efficacy Of An Antisense Oligonucleotide In Patients With Wild-Type Transthyretin Amyloid Cardiomyopathy (Senile Systemic Amyloidosis)AmyloidosisDrug: Isis 420915/GSK 299872Brigham and Women's HospitalGlaxoSmithKline;Ionis Pharmaceuticals, Inc.Withdrawn50 Years90 YearsBoth0Phase 2NULL
13EUCTR2013-004561-13-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
14EUCTR2013-004561-13-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
15EUCTR2013-004561-13-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
16EUCTR2012-001831-30-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
17EUCTR2013-004561-13-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
18NCT02175004
(ClinicalTrials.gov)
June 201412/6/2014Open-Label Extension Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: IONIS-TTR RxIonis Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll135Phase 3United States;Argentina;Brazil;France;Germany;Italy;Portugal;Spain;United Kingdom;New Zealand
19EUCTR2012-001831-30-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
20EUCTR2013-004561-13-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
21EUCTR2012-001831-30-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
22EUCTR2012-001831-30-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
23EUCTR2012-001831-30-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
24NCT01737398
(ClinicalTrials.gov)
March 15, 201327/11/2012Efficacy and Safety of Inotersen in 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 (NEURO-TTR Study)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: Inotersen;Drug: PlaceboIonis Pharmaceuticals, Inc.NULLCompleted18 Years82 YearsAll173Phase 2/Phase 3United States;Argentina;Brazil;France;Germany;Italy;New Zealand;Portugal;Spain;United Kingdom;Bulgaria
25EUCTR2012-001831-30-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
26EUCTR2017-005115-13-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
27EUCTR2017-005115-13-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