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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-011535-12-IT (EUCTR) | 14/01/2010 | 25/11/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Portugal;France;Germany;Italy;Sweden | ||
| 2 | EUCTR2009-011535-12-PT (EUCTR) | 09/09/2009 | 15/07/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | France;United States;Portugal;Argentina;Brazil;Germany;Italy;Sweden | |||
| 3 | EUCTR2009-011535-12-DE (EUCTR) | 26/08/2009 | 18/05/2009 | In preparation | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil | |||
| 4 | EUCTR2009-011535-12-FR (EUCTR) | 31/07/2009 | 19/06/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Portugal;France;Germany;Italy;Sweden | ||
| 5 | EUCTR2009-011535-12-SE (EUCTR) | 24/06/2009 | 10/06/2009 | To 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-201 | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden | ||
| 6 | EUCTR2008-001262-87-DE (EUCTR) | 16/03/2009 | 29/01/2009 | An 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 7 | EUCTR2007-006791-12-IT (EUCTR) | 15/09/2008 | 24/07/2008 | The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - ND | The 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-1006A | FOLDRX PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 16 | Germany;France;Italy | |||
| 8 | EUCTR2008-001262-87-PT (EUCTR) | 04/07/2008 | 21/04/2008 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 9 | EUCTR2008-001262-87-FR (EUCTR) | 04/07/2008 | 30/05/2008 | An 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 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 107 | Phase 2;Phase 3 | Portugal;France;Germany;Sweden | ||
| 10 | NCT00791492 (ClinicalTrials.gov) | July 2008 | 13/11/2008 | An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy | An Open-Label Extension Of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy | Familial Amyloid Polyneuropathy;ATTR-PN | Drug: Fx-1006A | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 86 | Phase 2/Phase 3 | Argentina;Brazil;France;Germany;Portugal;Sweden |
| 11 | EUCTR2008-001262-87-SE (EUCTR) | 23/06/2008 | 26/05/2008 | An 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 12 | EUCTR2006-002792-41-DE (EUCTR) | 08/10/2007 | 20/06/2007 | Safety 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 | Safety 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;United Kingdom;Germany;Spain;Sweden | ||
| 13 | EUCTR2006-002792-41-GB (EUCTR) | 06/07/2007 | 29/09/2006 | Safety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety 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. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2;Phase 3 | Portugal;Spain;Germany;United Kingdom;Sweden | ||
| 14 | NCT00409175 (ClinicalTrials.gov) | January 2007 | 6/12/2006 | Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis | Safety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled Study | Familial Amyloid Polyneuropathy | Drug: Fx-1006A;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 128 | Phase 2/Phase 3 | United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom |
| 15 | EUCTR2006-002792-41-PT (EUCTR) | 23/11/2006 | 14/09/2006 | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety 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. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;Germany;United Kingdom;Spain;Sweden | ||
| 16 | EUCTR2006-002792-41-SE (EUCTR) | 30/10/2006 | 01/09/2006 | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;Germany;United Kingdom;Spain;Sweden |