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 | JPRN-JapicCTI-111678 | 07/11/2011 | 02/11/2011 | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin | The Effect Of Transthyretin Stabilization, Safety, Tolerability, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin: A Phase 3, Open-Label(B3461010) | Transthyretin Familial Amyloid Polyneuropathy | Intervention name : tafamidis meglumine INN of the intervention : tafamidis meglumine Dosage And administration of the intervention : 20 mg QD Control intervention name : null | Pfizer Japan Inc. | NULL | 20 | 75 | BOTH | 10 | Phase 3 | NULL | |
| 2 | NCT01435655 (ClinicalTrials.gov) | November 2011 | 13/9/2011 | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin | The Effect On Transthyretin Stabilization, Safety, Tolerablity, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30m Or Non-v30m Transthyretin: A Phase Iii, Open-label Study | Transthyretin Familial Amyloid Polyneuropathy | Drug: tafamidis | Pfizer | NULL | Completed | 20 Years | 75 Years | All | 10 | Phase 3 | Japan |
| 3 | 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 | |||
| 4 | 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 | |||
| 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 |