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 | 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 | EUCTR2016-000489-50-IT (EUCTR) | 03/10/2017 | 08/06/2021 | Evaluation of efficacy and safety of NEOD001 in subjects with light chain (AL) amyloidosis with hepatic involvement | A Phase II, Single Arm, Open Label, Efficacy and Safety Study of NEOD001 in Subjects with Light Chain (AL) Amyloidosis with Hepatic Involvement - --- | AL amyloidosis with hepatic involvement MedDRA version: 20.0;Level: PT;Classification code 10075251;Term: Hepatic amyloidosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 Product Code: NEOD001 Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Italy | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | NCT03154047 (ClinicalTrials.gov) | June 14, 2017 | 28/4/2017 | Study in Subjects With Light Chain (AL) Amyloidosis | 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) | AL Amyloidosis | Drug: NEOD001 | Prothena Therapeutics Ltd. | NULL | Terminated | 18 Years | N/A | All | 80 | Phase 2 | United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | NCT02632786 (ClinicalTrials.gov) | March 2016 | 9/12/2015 | The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis | 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 | AL Amyloidosis | Drug: NEOD001;Drug: Placebo | Prothena Therapeutics Ltd. | NULL | Completed | 18 Years | N/A | All | 129 | Phase 2 | United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom |
| 13 | 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 | ||
| 14 | NCT02613182 (ClinicalTrials.gov) | February 2016 | 18/11/2015 | Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis | Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis | AL Amyloidosis | Drug: NEOD001 | Prothena Therapeutics Ltd. | NULL | Terminated | N/A | N/A | All | 34 | Phase 2 | United States |
| 15 | NCT02312206 (ClinicalTrials.gov) | February 2015 | 2/12/2014 | The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis | Primary Systemic (AL) Amyloidosis | Drug: NEOD001;Other: Placebo | Prothena Therapeutics Ltd. | NULL | Terminated | 18 Years | N/A | All | 260 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |