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 202 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) | August 1, 2023 | 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 | NCT05486481 (ClinicalTrials.gov) | April 1, 2023 | 1/8/2022 | Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation ( ... | A Multicenter Phase 1/2 Study of Venetoclax / Daratumumab / Dexamethasone for Previously Treated Systemic Light-Chain Amyloidosis Patients With Translocation (11;14) (ALTITUDE STUDY) A Multicenter Phase 1/2 Study of Venetoclax / Daratumumab / Dexamethasone for Previously Treated Sys ... | AL Amyloidosis;Light Chain (AL) Amyloidosis;Systemic Light Chain Disease | Drug: Venetoclax;Drug: Dexamethasone;Drug: Daratumumab | Sandy Wong, MD | Janssen Pharmaceuticals;AbbVie | Not yet recruiting | 18 Years | N/A | All | 78 | Phase 1/Phase 2 | United States |
| 3 | 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 |
| 4 | 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 |
| 5 | NCT05184088 (ClinicalTrials.gov) | January 13, 2023 | 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 | pharmtrace klinische Entwicklung GmbH | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | Spain |
| 6 | NCT05451771 (ClinicalTrials.gov) | October 26, 2022 | 6/7/2022 | Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis | An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Sy ... | AL Amyloidosis | Drug: Venetoclax Oral Tablet, 200 mg;Device: FISH assay;Drug: Venetoclax Oral Tablet, 400 mg;Drug: Dexamethasone Oral, 10 mg;Drug: Dexamethasone Oral, 20 mg;Drug: Daratumumab Injection;Drug: Bendamustine;Drug: Pomalidomide;Drug: Ixazomib;Drug: Venetoclax MTD with Dexamethasone Drug: VenetoclaxOral Tablet, 200 mg;Device: FISH assay;Drug: VenetoclaxOral Tablet, 400 mg;Drug: Dex ... | Rajshekhar Chakraborty, MD | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 53 | Phase 1/Phase 2 | United States |
| 7 | 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 ALamyloid ... | 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 ALamyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: C ... | 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 ... | ||
| 8 | 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 | ||
| 9 | 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 ALAmyloidos ... | 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 ... |
| 10 | 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 |