Shp655    (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12

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.
12 / 74 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003348-10-GB
(EUCTR)
17/11/202014/09/2020A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655)A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) - Baxalta TAK-755-3002 Continuation study to 281102 congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13
Product Code: TAK-755 orBAX930 or SHP655
INN or Proposed INN: Apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
INN or Proposed INN: Apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;Portugal;Serbia;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
2EUCTR2018-003775-35-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy
3EUCTR2017-000858-18-IT
(EUCTR)
16/10/201915/02/2018A 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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
BAXALTA INNOVATIONS GMBHNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy
4NCT03922308
(ClinicalTrials.gov)
October 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
5EUCTR2017-000858-18-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
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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 3United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-003775-35-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
7EUCTR2018-003775-35-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]
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
33Phase 2France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland
8EUCTR2017-000858-18-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
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
INN or Proposed INN: apademtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 3United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy
9EUCTR2017-000858-18-ES
(EUCTR)
27/11/201718/09/2017A 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: 100000013328;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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Canada;Spain;Austria;Germany;Japan;Italy;United Kingdom;Switzerland
10EUCTR2017-000858-18-GB
(EUCTR)
12/09/201714/07/2017A 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 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
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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 3United States;France;Canada;Poland;Spain;Austria;Germany;Switzerland;Japan;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-000858-18-PL
(EUCTR)
22/07/2019A 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
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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLNAFemale: yes
Male: yes
68Phase 3France;United States;Canada;Spain;Poland;Austria;Germany;Japan;Italy;United Kingdom;Switzerland
12EUCTR2017-000858-18-FR
(EUCTR)
12/01/2018A 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
INN or Proposed INN: apadamtase alfa
Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
Baxalta Innovations GmbHNULLNAFemale: yes
Male: yes
60Phase 3United States;France;Canada;Poland;Spain;Austria;Germany;Japan;Italy;United Kingdom;Switzerland