28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
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 215 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 | NCT05692908 (ClinicalTrials.gov) | March 2023 | 11/1/2023 | An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients Wit ... | An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129 ... | Light Chain (AL) Amyloidosis | Biological: STI-6129 | Sorrento Therapeutics, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 36 | Phase 1 | NULL |
| 2 | NCT04695340 (ClinicalTrials.gov) | February 2023 | 4/1/2021 | Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis | Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis | Familial Amyloidosis | Dietary Supplement: Psyllium | Centre Hospitalier Universitaire de Nice | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | France |
| 3 | EUCTR2020-000713-32-CZ (EUCTR) | 19/09/2022 | 07/02/2022 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloi ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasm ... | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: ... | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) ... | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | Russian Federation;United States;Czechia;Japan;Korea, Democratic People's Republic of;United Kingdom;Switzerland;Spain;Greece;Canada;Czech Republic;Austria;Netherlands;Belgium;Brazil;Poland;Italy;Israel;Australia;France;Germany Russian Federation;United States;Czechia;Japan;Korea, Democratic People's Republic of;United Kingdom ... | ||
| 4 | EUCTR2021-002639-48-DE (EUCTR) | 25/07/2022 | 15/12/2021 | 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 | ||
| 5 | JPRN-jRCT2031220037 | 20/06/2022 | 23/04/2022 | A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloido ... | 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 - AFFIRM-AL A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ... | Light Chain (AL) Amyloidosis | - Birtamimab group: Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy - Placebo group: Intravenous 0.9% Saline administration as a placebo every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy - Birtamimabgroup: Intravenous administration of 24 mg/kg birtamimabevery 28 days. Bortezomib-contain ... | Nie Christie | NULL | Recruiting | >= 18age old | Not applicable | Both | 16 | Phase 3 | Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic of Korea;Netherlands;New Zealand;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;United States;Japan Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic ... |
| 6 | EUCTR2021-002639-48-NL (EUCTR) | 10/06/2022 | 09/02/2022 | 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 | United States;France;Greece;Canada;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 7 | EUCTR2021-001427-40-SE (EUCTR) | 26/04/2022 | 28/01/2022 | Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthy ... | An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients ... | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classificat ... | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive na ... | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Germany;New Zealand;Sweden Portugal;United States;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Ger ... | ||
| 8 | EUCTR2021-001427-40-ES (EUCTR) | 12/04/2022 | 25/01/2022 | Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthy ... | An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients ... | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classificat ... | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive na ... | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Portugal;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Germany;New Zealand;Sweden United States;Portugal;Taiwan;Spain;Turkey;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Ger ... | ||
| 9 | 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 | ||
| 10 | 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] AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded ... | 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;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Korea, Republic of Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary ... |