CABLIVI ( 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3

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_
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agemin
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agemax
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PhaseCountries
1EUCTR2022-001177-31-DE
(EUCTR)
15/09/202229/06/2022Caplacizumab and immunosuppressive therapy without first line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpuraAn open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura Thrombotic Thrombocytopenic Purpura
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]
Trade Name: Cablivi®
Product Name: Cablivi®
Product Code: ALX0081
INN or Proposed INN: Caplacizumab
Other descriptive name: Nanobody directed towards the human A1 domain of von Willebrand factor
Trade Name: Cablivi®
Product Name: Cablivi®
Product Code: ALX0081
INN or Proposed INN: Caplacizumab
Other descriptive name: Nanobody directed towards the human A1 domain of von Willebrand factor
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Greece;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Germany;Netherlands;Japan
2NCT04985318
(ClinicalTrials.gov)
March 25, 202121/7/2021Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTPRetrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020Acquired Thrombotic Thrombocytopenic PurpuraDrug: Cablivi®University of CologneNULLRecruiting18 YearsN/AAll350Germany
3EUCTR2020-005288-30-FR
(EUCTR)
28/12/202006/11/2020Efficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm studyEfficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm study - CAPLAVIE acquired thrombotic thrombocytopenic purpura
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] - Skin and Connective Tissue Diseases [C17]
Trade Name: CABLIVICHU de RouenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 2France