64. 血栓性血小板減少性紫斑病 Thrombotic thrombocytopenic purpura Clinical trials / Disease details
臨床試験数 : 86 / 薬物数 : 81 - (DrugBank : 20) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 63
| 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 | EUCTR2018-003775-35-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 | ||
| 2 | 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 | ||
| 3 | NCT03922308 (ClinicalTrials.gov) | October 9, 2019 | 5/4/2019 | Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (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) | Other: Placebo;Drug: SHP655;Other: Standard of Care | Shire | Takeda Development Center Americas, Inc. | Completed | 18 Years | 75 Years | All | 28 | Phase 2 | United States;Canada;France;Germany;Italy;Spain;United Kingdom |
| 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 | ||
| 6 | NCT03393975 (ClinicalTrials.gov) | October 13, 2017 | 5/10/2017 | A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP) | A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]) | Purpura, Thrombotic Thrombocytopenic | Biological: BAX930;Biological: Standard of care | Baxalta now part of Shire | Takeda Development Center Americas, Inc. | Recruiting | N/A | 70 Years | All | 57 | Phase 3 | United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom |