Fx-1006a    (DrugBank: Fx-1006A)

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16

28. 全身性アミロイドーシス [臨床試験数:212,薬物数:234(DrugBank:72),標的遺伝子数:54,標的パスウェイ数:170
Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
16 / 212 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-011535-12-IT
(EUCTR)
14/01/201025/11/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - NDOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND Patients with Transthyretin Amyloidosis
MedDRA version: 12.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
FOLDRX PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;Germany;France;Italy;Sweden
2EUCTR2009-011535-12-PT
(EUCTR)
09/09/200915/07/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-,2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110France;United States;Portugal;Argentina;Brazil;Germany;Italy;Sweden
3EUCTR2009-011535-12-DE
(EUCTR)
26/08/200918/05/2009In preparationOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil
4EUCTR2009-011535-12-FR
(EUCTR)
31/07/200919/06/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat
FoldRx Pharmaceuticals, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;Germany;France;Italy;Sweden
5EUCTR2009-011535-12-SE
(EUCTR)
24/06/200910/06/2009To obtain additional long-term, safety and efficacy data for tafamidis in subjects with transthyretin (TTR) familial amyloid polyneuropathy (TTR-FAP) and to continue to provide the Tafamidis to subjects with TTR-FAP who have completed Protocol Fx-006 or Protocol Fx1A-201Open-Label Safety and Efficacy Evaluation of Fx-1006A in Subjects with Transthyretin (TTR) Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Clinical trial image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Commerical image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-001262-87-DE
(EUCTR)
16/03/200929/01/2009An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
7EUCTR2007-006791-12-IT
(EUCTR)
15/09/200824/07/2008The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - NDThe Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - ND Patients with Non-V30M Transthyretin Amyloidosis
MedDRA version: 9.1;Level: LLT;Classification code 10016202;Term: Familial amyloidosis
Product Code: Fx-1006AFOLDRX PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
16Germany;France;Italy
8EUCTR2008-001262-87-PT
(EUCTR)
04/07/200821/04/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
9EUCTR2008-001262-87-FR
(EUCTR)
04/07/200830/05/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
10NCT00791492
(ClinicalTrials.gov)
July 200813/11/2008An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyAn Open-Label Extension Of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyFamilial Amyloid Polyneuropathy;ATTR-PNDrug: Fx-1006APfizerNULLCompleted18 Years75 YearsAll86Phase 2;Phase 3Argentina;Brazil;France;Germany;Portugal;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-001262-87-SE
(EUCTR)
23/06/200826/05/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
12EUCTR2006-002792-41-DE
(EUCTR)
08/10/200720/06/2007Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicableSafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicable Familial Amyloid Polyneuropathy (FAP)
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;United Kingdom;Germany;Spain;Sweden
13EUCTR2006-002792-41-GB
(EUCTR)
06/07/200729/09/2006Safety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;Spain;Germany;United Kingdom;Sweden
14NCT00409175
(ClinicalTrials.gov)
January 20076/12/2006Safety and Efficacy Study of Fx-1006A in Patients With Familial AmyloidosisSafety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled StudyFamilial Amyloid PolyneuropathyDrug: Fx-1006A;Drug: PlaceboPfizerNULLCompleted18 Years75 YearsAll128Phase 2;Phase 3United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom
15EUCTR2006-002792-41-PT
(EUCTR)
23/11/200614/09/2006Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;Germany;United Kingdom;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-002792-41-SE
(EUCTR)
30/10/200601/09/2006Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).
MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;Germany;United Kingdom;Spain;Sweden