Darzalex ( DrugBank: - )

3 diseases

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	3
49	全身性エリテマトーデス	1
63	特発性血小板減少性紫斑病	1

28. 全身性アミロイドーシス

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	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-NL (EUCTR)	24/07/2019	08/07/2019	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	France;Greece;Netherlands;Italy
3	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	France;Greece;Netherlands;Italy

49. 全身性エリテマトーデス

臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

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	EUCTR2021-000962-14-DE (EUCTR)	02/07/2021	19/04/2021	A drug trial to evaluate the safety and efficacy of daratumumab, an agent already approved for other diseases, in combination with standard background anti-rheumatic therapy in patients with moderate-to-severe systemic lupus erythematosus	A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus - DARALUP	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414	Charité - Universitätsmedizin Berlin	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 2	Germany

63. 特発性血小板減少性紫斑病

臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139

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	EUCTR2019-004683-22-DK (EUCTR)	12/07/2022	17/05/2022	Daratumumab as a treatment for adult immune thrombocytopenia	Daratumumab as a treatment for adult immune thrombocytopenia - The DART-study	Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Darzalex Product Name: Daratumumab Product Code: L01FC01 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38	Ostfold Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	21	Phase 2	Denmark;Norway

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