28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 261 / 薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
| 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 | EUCTR2015-005333-49-GB (EUCTR) | 30/06/2016 | 04/04/2016 | A study to look at the long-term efficacy and safety of ALN-TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Multicenter, Multinational, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Revusiran in Patients with Transthyretin-mediated Familial Amyloidotic Cardiomyopathy | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Revusiran Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Mexico;Canada;Spain;Brazil;Belgium;Germany;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2014-003835-20-DE (EUCTR) | 24/06/2015 | 02/12/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2014-003835-20-SE (EUCTR) | 20/05/2015 | 27/11/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2014-003835-20-IT (EUCTR) | 05/05/2015 | 09/03/2016 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) - na | Trasthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 20.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC | ALNYLAM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Spain;Brazil;Belgium;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2014-003835-20-ES (EUCTR) | 30/03/2015 | 14/01/2015 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: NA Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Brazil;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 6 | EUCTR2014-003835-20-BE (EUCTR) | 25/03/2015 | 03/02/2015 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Spain;Belgium;Germany;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2014-003835-20-GB (EUCTR) | 26/11/2014 | 17/10/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart. | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Brazil;Belgium;Spain;Germany;Italy;France;United States;Canada;United Kingdom;Sweden |