Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 28 | 全身性アミロイドーシス | 11 |
28. 全身性アミロイドーシス
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
Showing 1 to 10 of 11 diseases
| 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 study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who ... | 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) A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Su ... | 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] The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who ... | 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) A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Su ... | 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] The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 Evaluation of efficacy and safety of NEOD001 in subjects with light chain (AL) amyloidosis with hepa ... | A Phase II, Single Arm, Open Label, Efficacy and Safety Study 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 Chai ... | 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] AL amyloidosis with hepatic involvement MedDRA version: 20.0;Level: PT;Classification code 10075251; ... | Product Name: NEOD001 Product Code: NEOD001 Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 Product Code: NEOD001 Other descriptive name: Humanized IgG1, kappa anti-serum a ... | 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 study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who ... | 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) A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Su ... | 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] The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who ... | 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) A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Su ... | 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] The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who ... | 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) A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Su ... | 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] The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 | 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 study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosi ... | 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 A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subj ... | 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] Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that prod ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 | ||
| 8 | 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 study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosi ... | 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 A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subj ... | 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] Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that prod ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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 | ||
| 9 | 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 study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosi ... | 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 A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subj ... | 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] Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that prod ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | 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-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 study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloid ... | 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 A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subj ... | 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] Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused ... | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-seru ... | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom |