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 | NCT04115956 (ClinicalTrials.gov) | August 6, 2020 | 29/8/2019 | A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy | AL Amyloidosis | Drug: Melphalan-Flufenamide (Melflufen);Drug: Dexamethasone | Oncopeptides AB | PRA Health Sciences | Terminated | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland |
| 2 | EUCTR2018-002761-19-DE (EUCTR) | 06/03/2020 | 12/08/2019 | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-002761-19-ES (EUCTR) | 05/02/2020 | 09/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-002761-19-GR (EUCTR) | 03/12/2019 | 15/11/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2018-002761-19-NO (EUCTR) | 15/11/2019 | 01/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy | ||
| 6 | EUCTR2018-002761-19-IT (EUCTR) | 25/10/2019 | 29/01/2021 | It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis. Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy - NA | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen Product Code: [Melflufen] INN or Proposed INN: melphalan fulfenamide hydrochloride Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: [H02AB02] INN or Proposed INN: DESAMETASONE | ONCOPEPTIDES AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 1;Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2018-002761-19-PL (EUCTR) | 24/10/2019 | 07/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | Italy;United Kingdom;Germany;Norway;Israel;Poland;Spain;Greece;Czech Republic;Czechia;United States;France | ||
| 8 | EUCTR2018-002761-19-CZ (EUCTR) | 21/10/2019 | 31/07/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom |