Daratumumab co-formulated with recombinant human hyaluronidase (rhuph20) (DrugBank: Recombinant human hyaluronidase, Daratumumab, Hyaluronidase)
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 | 7 |
| 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-FR (EUCTR) | 23/01/2020 | 02/12/2019 | 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: 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 | ||
| 2 | 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 | ||
| 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 | Greece;Netherlands;Italy | ||
| 4 | EUCTR2016-001737-27-PL (EUCTR) | 06/09/2018 | 16/07/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 5 | EUCTR2016-001737-27-GR (EUCTR) | 16/04/2018 | 22/03/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 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 |
| 6 | EUCTR2016-001737-27-ES (EUCTR) | 06/02/2018 | 23/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 7 | EUCTR2016-001737-27-HU (EUCTR) | 25/01/2018 | 28/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden |