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
Showing 1 to 10 of 198 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 | NCT05145816 (ClinicalTrials.gov) | April 1, 2022 | 23/11/2021 | Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis | A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refracto ... | AL Amyloidosis;Amyloidosis | Drug: Belantamab mafodotin 2.5 mg/kg (6 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (4 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part 1 recommended dosages Drug: Belantamab mafodotin2.5 mg/kg (6 weeks);Drug: Belantamab mafodotin2.5 mg/kg (4 weeks);Drug: Be ... | University of Texas Southwestern Medical Center | GlaxoSmithKline | Not yet recruiting | 18 Years | N/A | All | 37 | Phase 1/Phase 2 | United States |
| 2 | NCT05184088 (ClinicalTrials.gov) | April 2022 | 6/1/2022 | Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis | An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safet ... | Cardiac Amyloidosis;AL Amyloidosis;ATTR Amyloidosis | Drug: [18F]florbetaben | Life Molecular Imaging GmbH | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Phase 3 | NULL |
| 3 | EUCTR2021-002639-48-ES (EUCTR) | 08/03/2022 | 28/12/2021 | A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ... | A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis - Aquarius A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ... | Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: Amyloid light-chain amyloidosis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ... | Trade Name: DAZARLEX Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JNJ-54767414 INN or Proposed INN: Daratumumab Other descriptive name: HuMax-CD38, 3003-005 Trade Name: DAZARLEX Product Name: Daratumumabco-formulated with recombinant human hyaluronidase (rHu ... | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | NCT04984330 (ClinicalTrials.gov) | March 2022 | 29/7/2021 | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Amyloid;Amyloidosis;AL Amyloidosis | Drug: Selinexor;Drug: Dexamethasone | Weill Medical College of Cornell University | Karyopharm Therapeutics Inc | Recruiting | 18 Years | N/A | All | 10 | Early Phase 1 | United States |
| 5 | EUCTR2021-000037-14-NL (EUCTR) | 22/02/2022 | 04/08/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab ... | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ... | 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] ALamyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded i ... | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive nam ... | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary ... | ||
| 6 | EUCTR2021-000037-14-IT (EUCTR) | 21/01/2022 | 26/11/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standardof Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab ... | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ... | 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 ofabnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, andhepatic 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] ALamyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded i ... | Product Name: Birtamimab Product Code: [Birtamimab] INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid Product Name: paracetamolo Zentiva Italia Product Code: [NA] INN or Proposed INN: PARACETAMOLO Trade Name: Bortezomib Accord Product Name: Bortezomib Accord Product Code: [Bortezomib Accord] INN or Proposed INN: BORTEZOMIB Other descriptive name: Bortezomib D-mannitol Product Name: Zirtec Product Code: [NA] INN or Proposed INN: CETIRIZINA DICLORIDRATO Other descriptive name: NA Product Name: Aciclin Product Code: [NA] INN or Proposed INN: ACICLOVIR Product Name: Birtamimab Product Code: [Birtamimab] INN or Proposed INN: BIRTAMIMAB Other descriptive n ... | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Germany;Netherlands;Korea, Republic of United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary ... | ||
| 7 | NCT05235269 (ClinicalTrials.gov) | November 30, 2021 | 10/12/2021 | A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloid ... | A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitatio ... | Amyloidosis | Drug: I124-AT01 only | Attralus, Inc. | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 8 | NCT05199337 (ClinicalTrials.gov) | November 30, 2021 | 9/1/2022 | Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis | A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light ... | Amyloidosis;AL Amyloidosis | Drug: ZN-d5 | K-Group Alpha, Inc. | NULL | Recruiting | 18 Years | N/A | All | 135 | Phase 1/Phase 2 | United States |
| 9 | NCT05201911 (ClinicalTrials.gov) | November 30, 2021 | 2/12/2021 | A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloido ... | A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select Organs in Patients With Systemic Amyloidosis A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select ... | Amyloidosis; Systemic | Drug: 124I-AT03 | Attralus, Inc. | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 10 | EUCTR2021-000037-14-DE (EUCTR) | 12/11/2021 | 26/05/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab ... | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ... | 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] ALamyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded i ... | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive nam ... | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary ... |