BAX930 or SHP655 or TAK755 ( 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2

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000858-18-DE
(EUCTR)
09/10/201931/08/2017A Phase 3, randomized, controlled study in the treatment of severe congenital thrombotic thrombocytopenic purpura, with BAX 930.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]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX930 severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP])
MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Product Code: BAX930 or SHP655 or TAK755
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Product Code: BAX930 or SHP655 or TAK755
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Product Code: BAX930 or SHP655 or TAK755
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 3France;United States;Canada;Poland;Spain;Austria;Germany;Switzerland;United Kingdom;Italy;Japan
2EUCTR2017-000858-18-AT
(EUCTR)
20/03/201805/12/2017A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930.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]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP])
MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Product Code: BAX930 or SHP655 or TAK755
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Trade Name: Octaplas SD
Product Name: Octaplas®LG
INN or Proposed INN: Octaplas
Other descriptive name: Pooled Plasma (Human), Solvent/Detergent Treated
Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Product Code: BAX930 or SHP655 or TAK755
INN or Proposed INN: apademtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
57Phase 3France;United States;Canada;Poland;Spain;Austria;Germany;Switzerland;United Kingdom;Italy;Japan