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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2022-001940-36-ES
(EUCTR)
13/02/202322/12/2022A Phase 2b study of TAK-755 (rADAMTS13) with minimal to no PEX in the treatment of patients with iTTPA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Argentina;United States;United Kingdom;Switzerland;Spain;Greece;Canada;Austria;Poland;Italy;Israel;France;Germany
2EUCTR2018-003775-35-IT
(EUCTR)
21/02/202029/01/2021A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTPA 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 GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2France;United States;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy
3EUCTR2018-003775-35-DE
(EUCTR)
18/10/201930/04/2019A Phase 2, randomized, placebo-controlled, double-blind study ofrADAMTS-13 (SHP655) in the treatment of patients with aTTPA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
33Phase 2United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy
4EUCTR2018-003775-35-GB
(EUCTR)
03/07/201913/02/2019A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTPA 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2United States;France;Canada;Spain;Germany;Italy;United Kingdom
5EUCTR2018-003775-35-ES
(EUCTR)
13/06/201911/06/2019 A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTPA 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 GmbHNULLAuthorised-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): noFrance;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland