64. 血栓性血小板減少性紫斑病 [臨床試験数:74,薬物数:76(DrugBank:19),標的遺伝子数:15,標的パスウェイ数:57

Searched query = "Thrombotic thrombocytopenic purpura", "TTP", "Upshaw-Schulman syndrome", "USS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
5 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2018-003775-35-DE18/10/201930/04/2019A 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: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy
2NCT03922308October 9, 20195/4/2019Study 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) TreatmentAcquired Thrombotic Thrombocytopenic Purpura (aTTP)Other: Placebo;Drug: SHP655;Other: Standard of CareShireNULLRecruiting18 Years75 YearsAll30Phase 2United States;France;Germany;Spain;United Kingdom
3EUCTR2018-003775-35-GB03/07/201913/02/2019A 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: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem 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
4EUCTR2018-003775-35-ES13/06/201911/06/2019 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]
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
33 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland
5NCT03393975October 20, 20175/10/2017A Study of Prophylactic and On-demand Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP) With BAX 930 (rADAMTS13)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 Participants With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP) (Upshaw-Schulman Syndrome)Congenital Thrombotic Thrombocytopenic PurpuraBiological: BAX930;Biological: Standard of careBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/A70 YearsAll68Phase 3United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom