BAX930 - RECOMBINANT HUMAN ADAMTS13 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 64 | 血栓性血小板減少性紫斑病 | 5 |
64. 血栓性血小板減少性紫斑病
臨床試験数 : 92 / 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
| 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 | EUCTR2022-001940-36-ES (EUCTR) | 13/02/2023 | 22/12/2022 | A Phase 2b study of TAK-755 (rADAMTS13) with minimal to no PEX in the treatment of patients with iTTP | A Phase 2b, multicenter, randomized, double-blind study of safety and efficacy of TAK-755 (rADAMTS13) with minimal to no plasma exchange (PEX) in the treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP) | immune-mediated thrombotic thrombocytopenic purpura (iTTP) MedDRA version: 20.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: TAK-755 INN or Proposed INN: Apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Argentina;United States;United Kingdom;Switzerland;Spain;Greece;Canada;Austria;Poland;Italy;Israel;France;Germany | ||
| 2 | EUCTR2018-003775-35-IT (EUCTR) | 21/02/2020 | 29/01/2021 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - na | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: [SHP 655 (BAX 930)] INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | BAXALTA INNOVATIONS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 3 | EUCTR2018-003775-35-DE (EUCTR) | 18/10/2019 | 30/04/2019 | A Phase 2, randomized, placebo-controlled, double-blind study ofrADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovation GmbH | NULL | Not Recruiting | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 4 | EUCTR2018-003775-35-GB (EUCTR) | 03/07/2019 | 13/02/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - Baxalta SHP655-201 | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2018-003775-35-ES (EUCTR) | 13/06/2019 | 11/06/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland |