Darzalex (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 | 2 |
| 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 | EUCTR2018-004333-33-IT (EUCTR) | 01/08/2019 | 28/04/2020 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22/54767414AMY2005 | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMUMAB Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 Product Name: Decadron Product Code: H02AB02 Desametasone INN or Proposed INN: DEXAMETHASONE Other descriptive name: Dexamethasone | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 2 | EUCTR2018-004333-33-GR (EUCTR) | 08/07/2019 | 05/06/2019 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMUMAB Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Greece;Netherlands;Italy |