HYALURONIDASE ( DrugBank: Hyaluronidase )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 3 |
| 28 | 全身性アミロイドーシス | 15 |
| 65 | 原発性免疫不全症候群 | 6 |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 167 / 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
| 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 | JPRN-jRCT2051210110 | 07/12/2021 | 14/10/2021 | A Study of TAK-771 in Japanese Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) | A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese Subjects | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MM | Cohort 1: TAK-771 for CIDP Participants TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. Cohort 2: TAK-771 for MMN Participants TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. | Nishizawa Atsushi | NULL | Recruiting | >= 18age old | Not applicable | Both | 21 | Phase 3 | Japan |
| 2 | EUCTR2015-000828-28-NL (EUCTR) | 26/07/2016 | 30/11/2015 | Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed. | Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne | Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hyqvia Product Name: Hyqvia | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 3 | NCT02556437 (ClinicalTrials.gov) | June 2016 | 18/9/2015 | Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN) | Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Drug: HyQvia;Drug: Subcuvia | Johannes Jakobsen | Baxter Healthcare Corporation | Completed | 18 Years | 90 Years | All | 18 | Phase 2 | Denmark |
28. 全身性アミロイドーシス
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 | EUCTR2021-002639-48-ES (EUCTR) | 08/03/2022 | 28/12/2021 | 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 (AL) Amyloidosis - Aquarius | 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] | 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | EUCTR2016-001737-27-GB (EUCTR) | 08/10/2018 | 11/01/2018 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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-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 | Sweden;Korea, Republic of;China;Japan;Germany;Netherlands;Denmark;Australia;Romania;Brazil;Belgium;Poland;Canada;Mexico;Hungary;France;United Kingdom;Italy;Israel;Turkey;Spain;Greece;United States | ||
| 8 | EUCTR2016-001737-27-DK (EUCTR) | 22/08/2018 | 04/06/2018 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 9 | EUCTR2016-001737-27-SE (EUCTR) | 07/05/2018 | 20/11/2017 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 10 | 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 | ||
| 11 | EUCTR2016-001737-27-DE (EUCTR) | 16/04/2018 | 16/11/2017 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 12 | EUCTR2016-001737-27-NL (EUCTR) | 15/03/2018 | 29/11/2017 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | EUCTR2016-001737-27-BE (EUCTR) | 16/01/2018 | 16/11/2017 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 |
65. 原発性免疫不全症候群
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | JPRN-jRCT2031210457 | 24/01/2022 | 27/11/2021 | A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) | A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects with Primary Immunodeficiency Diseases (PID) | Primary Immunodeficiency Diseases (PID) | Epoch 1: TAK-771 Ramp up Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI will be increased from 1/3 of full dose to full dose in 3 weeks for participants who will receive TAK-771 once every 3 week, or from 1/4 of full dose to full dose in 6 weeks for participants who will receive TAK-771 once every 4 week. Epoch 2: TAK-771 Treatment Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24. | Nishizawa Atsushi | NULL | Recruiting | >= 2age old | Not applicable | Both | 15 | Phase 3 | Japan |
| 2 | EUCTR2012-000481-38-GB (EUCTR) | 28/06/2012 | 26/04/2012 | Assessment of the safety of Immunoglobulin and recombinant human hylaluronidase in the treatment of patients with primary immunodeficiency | Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Study in Europe - Tolerability and Safety of IG, 10% with rHuPH20 in PIDD | Primary Immunodeficiency Diseases MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Belgium;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | |||
| 3 | NCT01485796 (ClinicalTrials.gov) | December 29, 2011 | 2/12/2011 | Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD | Tolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) Facilitated Subcutaneous Treatment With Immune Globulin Infusion (Human), 10% in Subjects With Primary Immunodeficiency Diseases (PIDD) | Primary Immunodeficiency Diseases (PID) | Biological: Immune Globulin Infusion (Human), 10%;Biological: Recombinant human hyaluronidase | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 54 | Phase 2/Phase 3 | United States |
| 4 | NCT01175213 (ClinicalTrials.gov) | July 28, 2010 | 3/8/2010 | Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID | Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases (PID) | Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety);Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety);Biological: IV treatment with IGSC, 10% | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 66 | Phase 3 | United States |
| 5 | NCT00814320 (ClinicalTrials.gov) | December 18, 2008 | 23/12/2008 | Gammagard Liquid and rHuPH20 in PID | Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases (PID) | Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 89 | Phase 3 | United States;Canada |
| 6 | NCT00782106 (ClinicalTrials.gov) | December 4, 2006 | 29/10/2008 | Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously | Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID) | Primary Immunodeficiency Diseases (PID) | Biological: Recombinant human hyaluronidase + immune globulin intravenous | Baxalta now part of Shire | NULL | Completed | 16 Years | N/A | All | 11 | Phase 1/Phase 2 | United States |