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.
| 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 | EUCTR2016-004664-18-DE (EUCTR) | 09/02/2018 | 24/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2016-004664-18-AT (EUCTR) | 07/11/2017 | 20/09/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;Australia;Austria;Israel;Germany;Italy;United Kingdom;United States;Greece;Spain | ||
| 3 | EUCTR2016-004664-18-GR (EUCTR) | 27/09/2017 | 02/06/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2016-004664-18-GB (EUCTR) | 08/08/2017 | 09/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2016-004664-18-ES (EUCTR) | 31/07/2017 | 29/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 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 |
| 6 | EUCTR2015-004318-14-AT (EUCTR) | 07/07/2016 | 22/08/2016 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | France;United States;Greece;Spain;Australia;Austria;Israel;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2015-004318-14-DE (EUCTR) | 13/06/2016 | 26/11/2015 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | United States;France;Greece;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2015-004318-14-GR (EUCTR) | 21/04/2016 | 11/02/2016 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2015-004318-14-ES (EUCTR) | 10/03/2016 | 18/03/2016 | A study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains by plasma cells results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs of individuals with AL amyloidosis. MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2015-004318-14-GB (EUCTR) | 05/02/2016 | 27/11/2015 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | United States;France;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom |