64. 血栓性血小板減少性紫斑病 Thrombotic thrombocytopenic purpura Clinical trials / Disease details


臨床試験数 : 86 薬物数 : 81 - (DrugBank : 20) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 63

  
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PhaseCountries
1NCT05263193
(ClinicalTrials.gov)
March 16, 202222/2/2022Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP)Retrospective Data Collection of Pediatric Patients With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) Treated With CaplacizumabImmune-mediated Thrombocytopenic PurpuraDrug: CaplacizumabSanofiNULLNot yet recruitingN/A18 YearsAll30France
2EUCTR2020-003348-10-IT
(EUCTR)
15/02/202201/12/2021A 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) - TAK-755-3002 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
INN or Proposed INN: Apadamtase alfa
BAXALTA INNOVATIONS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
77Phase 3United States;Serbia;Portugal;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
3NCT05135442
(ClinicalTrials.gov)
December 1, 20216/11/2021Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTPThe Efficacy and Safety of Bortezomib as First-line Treatment for Acquired Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic Purpura, AcquiredDrug: Bortezomib InjectionPeking Union Medical College HospitalNULLNot yet recruiting18 Years80 YearsAll30Phase 4China
4NCT04720261
(ClinicalTrials.gov)
May 1, 202112/1/2021Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTPEfficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult Acquired Thrombotic Thrombocytopenic Purpura: A Phase II, Multicenter Non-inferiority Single-arm Study.Thrombotic Thrombocytopenic Purpura, AcquiredDrug: CaplacizumabUniversity Hospital, RouenNULLNot yet recruiting18 Years100 YearsAll125Phase 2NULL
5NCT04683003
(ClinicalTrials.gov)
April 14, 202110/12/2020A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic PurpuraA 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)Congenital Thrombotic Thrombocytopenic PurpuraBiological: TAK-755TakedaTakeda Development Center Americas, Inc.;ShireRecruitingN/A70 YearsAll77Phase 3United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom
6NCT04985318
(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
7EUCTR2020-005288-30-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
8EUCTR2020-003348-10-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
9NCT04588194
(ClinicalTrials.gov)
November 1, 202030/1/2020Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune ThrombocytopeniaRomiplostim in Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment for Immune ThrombocytopeniaImmune Thrombocytopenia;Thrombotic Thrombocytopenic PurpuraDrug: Romiplostim;Drug: Rituximab;Drug: DexamethasoneDavid Gomez AlmaguerNULLRecruiting16 Years90 YearsAll12Phase 2Mexico
10EUCTR2018-003775-35-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
11NCT04074187
(ClinicalTrials.gov)
October 21, 201914/8/2019A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab)SanofiNULLCompleted18 YearsN/AAll21Phase 2/Phase 3Japan
12JPRN-JapicCTI-194991
20/10/201908/10/2019A phase 3, randomized, controlled study of prophylactic and on-demandA 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]) severe congenital thrombotic thrombocytopenicpurpura (cTTP, Upshaw-Schulman Syndrome [USS],hereditary thrombotic thrombocytopenic purpura [hTTP]Intervention name : rADAMTS-13
INN of the intervention : -
Dosage And administration of the intervention : BAX930 is to be reconstituted using all the amount of the accompanying water for reconstitution and injected or dripped slowly intravenously. Normally, 40 (+/-4) international units per kg of body weight is administered at intervals of 1 to 2 weeks or according to the patient's symptoms. The frequency of dosing and dose level can be increased or decreased as appropriate according to the patient's symptoms.
Control intervention name : Standrd of Care treatment
INN of the control intervention : -
Dosage And administration of the control intervention : -
Baxalta now part of Shire(ICCC: IQVIA Services Japan K.K.)NULLrecruiting070BOTH4Phase 3Japan, North America, Europe
13EUCTR2018-003775-35-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
14EUCTR2017-000858-18-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
15NCT03922308
(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 CareShireTakeda Development Center Americas, Inc.Completed18 Years75 YearsAll28Phase 2United States;Canada;France;Germany;Italy;Spain;United Kingdom
16EUCTR2017-000858-18-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
57Phase 3France;United States;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Japan
17EUCTR2018-003775-35-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
18NCT04021173
(ClinicalTrials.gov)
July 201915/7/2019A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)Acquired Thrombotic Thrombocytopenic PurpuraDrug: Anfibatide;Drug: PlacebosLee's Pharmaceutical LimitedNULLNot yet recruiting18 YearsN/AAll74Phase 2China
19EUCTR2018-003775-35-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
20NCT03237819
(ClinicalTrials.gov)
May 27, 201813/6/2017Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive CareInterest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled TrialThrombotic Thrombocytopenic PurpuraDrug: Sulfate, Magnesium;Drug: Placebo - ConcentrateAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting18 YearsN/AAll74Phase 3France
21EUCTR2017-000858-18-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
57Phase 3France;United States;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Japan
22NCT03369314
(ClinicalTrials.gov)
March 2, 201830/11/2017Observational Study of the Use of octaplasLG®.Observational, Real-life Study of the Use of octaplasLG®.Thrombotic Thrombocytopenic PurpuraDrug: octaplasLG®OctapharmaNULLCompletedN/AN/AAll263France;New Caledonia
23EUCTR2017-000858-18-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 3United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy
24NCT03393975
(ClinicalTrials.gov)
October 13, 20175/10/2017A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)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])Purpura, Thrombotic ThrombocytopenicBiological: BAX930;Biological: Standard of careBaxalta now part of ShireTakeda Development Center Americas, Inc.RecruitingN/A70 YearsAll57Phase 3United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom
25EUCTR2017-000858-18-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
26EUCTR2017-001117-86-GB
(EUCTR)
25/07/201718/05/2018Elective rituximab in TTPA phase IV, prospective, randomised single-blind UK multicentre non-inferiority trial of low-dose versus standard dose rituximab for prevention of relapses in acquired TTP - Elective rituximab in TTP Acquired thrombotic thrombocytopenic purpura;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Mabthera
Product Name: Mabthera
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 4United Kingdom
27EUCTR2016-001503-23-NL
(EUCTR)
05/07/201719/07/2017Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany
28NCT01938404
(ClinicalTrials.gov)
June 6, 20172/9/2013Octaplas Adult TTP TrialPost-Marketing Requirement Study to Evaluate the Safety and Efficacy of Octaplas™ in Patients With Thrombotic Thrombocytopenic Purpura With Special Emphasis on Monitoring the Occurrence of Thromboembolic EventsThrombotic Thrombocytopenic PurpuraBiological: Octaplas;Drug: Standard PlasmaOctapharmaNULLTerminated18 YearsN/AAll1United States
29EUCTR2016-001503-23-DE
(EUCTR)
12/04/201703/01/2017Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 19.1;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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany
30EUCTR2016-001503-23-FR
(EUCTR)
07/02/201720/10/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 19.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Australia;Germany;Netherlands
31EUCTR2016-001503-23-GB
(EUCTR)
15/11/201615/08/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
104Phase 3United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany
32EUCTR2016-001503-23-CZ
(EUCTR)
31/10/201619/08/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
104Phase 3Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;United States
33EUCTR2016-001503-23-BE
(EUCTR)
21/10/201622/08/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
104Phase 3United States;Spain;Turkey;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany
34EUCTR2016-001503-23-HU
(EUCTR)
06/10/201610/08/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 19.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands
35NCT02878603
(ClinicalTrials.gov)
October 20164/8/2016Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)Acquired Thrombotic Thrombocytopenic PurpuraBiological: caplacizumabSanofiNULLCompleted18 YearsN/AAll104Phase 3United States;Austria;Belgium;Canada;Czechia;France;Hungary;Israel;Italy;Spain;Switzerland;Turkey;United Kingdom;Czech Republic
36NCT02854059
(ClinicalTrials.gov)
September 201627/7/2016IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) PatientsA Phase II Pilot Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients With Low ADAMTS13 ActivityPurpura, Thrombotic ThrombocytopenicBiological: IdeS (0.25 mg/kg);Biological: IdeS (0.50 mg/kg)Hansa Biopharma ABUniversity College London HospitalsTerminated18 YearsN/AAll2Phase 2United Kingdom
37EUCTR2016-001503-23-ES
(EUCTR)
25/08/201615/07/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 19.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany
38EUCTR2016-001503-23-AT
(EUCTR)
16/08/201614/07/2016Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
104Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany
39EUCTR2016-000249-30-GB
(EUCTR)
14/07/201619/05/2016IDES IN ASYMPTOMATIC TTP PATIENTSA PHASE II PILOT STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACODYNAMICS AND PHARMACOKINETICS OF IDES IN ASYMPTOMATIC ANTIBODY-MEDIATED THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) PATIENTS WITH LOW ADAMTS13 ACTIVITY - IDES IN ASYMPTOMATIC ANTIBODY-MEDIATED TTP PATIENTS WITH LOW ADAMTS13 Asymptomatic antibody-mediated thrombotic thrombocytopenic purpura (TTP) with low ADAMTS13 activity
MedDRA version: 19.0;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: HMED-IdeS
Product Code: HMED-IdeS
Other descriptive name: IdeS
Hansa Medical ABNULLNot Recruiting Female: yes
Male: yes
6 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
40EUCTR2015-001098-42-NL
(EUCTR)
11/04/201609/09/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 19.0;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: Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
41EUCTR2015-001098-42-DE
(EUCTR)
10/12/201504/08/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. 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] - Blood and lymphatic diseases [C15]
Product Name: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
42NCT02553317
(ClinicalTrials.gov)
November 201514/9/2015Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic PurpuraA Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic PurpuraAcquired Thrombotic Thrombocytopenic PurpuraBiological: Caplacizumab;Biological: PlaceboAblynxNULLCompleted18 YearsN/AAll145Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;Switzerland;Turkey;United Kingdom;Czech Republic
43EUCTR2015-001098-42-ES
(EUCTR)
29/10/201531/07/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 18.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
44EUCTR2015-001098-42-HU
(EUCTR)
15/10/201504/08/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. - HERCULES Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 19.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany
45EUCTR2015-001098-42-AT
(EUCTR)
06/10/201503/08/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. - HERCULES Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 19.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany
46EUCTR2015-001098-42-CZ
(EUCTR)
01/10/201529/07/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. - HERCULES Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 19.0;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: Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany
47EUCTR2015-001098-42-BE
(EUCTR)
27/08/201513/07/2015A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. Acquired Thrombotic thrombocytopenic purpura
MedDRA version: 18.0;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: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
48EUCTR2012-003221-19-PL
(EUCTR)
31/03/201509/02/2015Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTPBAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.1;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
INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
14Phase 1United States;Poland;Austria;Germany;United Kingdom;Japan;Switzerland
49EUCTR2012-003221-19-DE
(EUCTR)
12/03/201507/12/2012Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTPBAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;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
INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
14Phase 1United States;Poland;Austria;Germany;United Kingdom;Japan;Switzerland
50EUCTR2014-001032-11-PL
(EUCTR)
22/10/201421/08/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Malaysia;Belgium;Poland;Singapore;Lithuania;Bulgaria;New Zealand;Italy
51EUCTR2014-001032-11-BE
(EUCTR)
10/10/201425/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Belarus;Hong Kong;Taiwan;Thailand;Turkey;Lithuania;United Kingdom;Italy;Switzerland;Belgium;Malaysia;Poland;Bulgaria;Germany;New Zealand
52EUCTR2014-001032-11-LT
(EUCTR)
30/09/201402/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of study drug OMS721 in adults with thromboticmicroangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study toevaluate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS)- hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Poland;Malaysia;Belgium;Singapore;Lithuania;Bulgaria;New Zealand;Italy
53NCT02216084
(ClinicalTrials.gov)
September 30, 201412/8/2014Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)Hereditary Thrombotic Thrombocytopenic Purpura (TTP)Drug: Recombinant ADAMTS13Baxalta now part of ShireNULLCompleted12 Years65 YearsAll16Phase 1United States;Austria;Germany;Japan;Poland;Switzerland;United Kingdom
54JPRN-JMA-IIA00160
20/01/201416/01/2014Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic PurpuraInvestigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura Thrombotic Thrombocytopenic PurpuraIntervention type:DRUG. Intervention1:Rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:1st cycle
Initiate infusion at a rate of 50 mg/hr. In the absence of adverse events such as allergic reaction or infusion reaction, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
Subsequent cycles
If patients did not experience or experience grade 2 or less severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 100 mg/hr and increase infusion rate by 100 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
If patients experience grade 3 or more severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 50 mg/hr and increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr..
Saitama Medical University , Department of General Internal Medicine, Yoshitaka MiyakawaNULLCompleted>=20 YEARS<=79 YEARSBOTH8Phase 2Japan
55ChiCTR-ONRC-13003194
2013-07-012013-04-18The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura.The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura. Thrombotic Thrombocytopenic Purpuraexperimental group:rituximab;Control group:No intervention;The First Affiliated Hospital Of Soochow UniversityNULLRecruiting875Bothexperimental group:70;Control group:30;I (Phase 1 study)China
56EUCTR2012-003221-19-GB
(EUCTR)
05/02/201313/12/2012 Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTP BAX 930 (rADAMTS13) A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;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
INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Baxalta Innovations GmbHNULLNot Recruiting Female: yes
Male: yes
14 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;Japan;United Kingdom
57EUCTR2012-003221-19-AT
(EUCTR)
17/12/201212/11/2012Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTPBAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;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
INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
14Phase 1United States;Poland;Austria;Germany;United Kingdom;Japan
58NCT01754545
(ClinicalTrials.gov)
September 201212/12/2012Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic PurpuraProphylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic PurpuraPurpura, Thrombotic ThrombocytopenicDrug: Octaplas infusion and placebo (group 1);Drug: Octaplas infusion and placebo (group 2)St. Olavs HospitalNorwegian University of Science and TechnologyWithdrawn18 Years65 YearsBoth0Phase 4Norway
59NCT01554514
(ClinicalTrials.gov)
August 20128/3/2012Low Dose Rituximab in Thrombotic Thrombocytopenic PurpuraAdjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 DeficiencyThrombotic Thrombocytopenic PurpuraBiological: rituximabWashington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll19Phase 2United States
60EUCTR2010-019375-30-ES
(EUCTR)
10/02/201117/11/2010A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.Estudio en fase II, ciego-simple, randomizado, controlado con placebo, para estudiar la eficacia y la seguridad del Nanobody Anti- Factor Von- Willebrand administrado como tratamiento adyuvante en pacientes con Púrpura Trombocitopénica Trombótica adquirida - Acquired thrombotic thrombocytopenic purpura (TTP)Púrpura Trombocitopénica Trombótica adquirida (PTT)
MedDRA version: 13.1;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Anti-von Willebrand Factor Nanobody
Product Code: ALX-0081
Other descriptive name: Anti-von Willebrand Factor Nanobody
AblynxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 2Germany;United Kingdom;Belgium;Spain;Italy;Austria
61NCT01151423
(ClinicalTrials.gov)
January 201125/6/2010Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)A Phase II, Single-blind, Randomized, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired Thrombotic Thrombocytopenic PurpuraAcquired Thrombotic Thrombocytopenic PurpuraBiological: Caplacizumab;Biological: PlaceboAblynxNULLCompleted18 YearsN/AAll75Phase 2United States;Australia;Austria;Belgium;Bulgaria;France;Germany;Israel;Italy;Romania;Spain;Switzerland;United Kingdom
62EUCTR2010-019375-30-AT
(EUCTR)
07/12/201027/07/2010A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura. Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 14.1;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: Anti-von Willebrand Factor Nanobody, Caplacizumab
Product Code: ALX-0081
Other descriptive name: Anti-von Willebrand Factor Nanobody
AblynxNULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;Canada;Spain;Belgium;Austria;Israel;Russian Federation;Germany;Italy;United Kingdom;Switzerland
63EUCTR2010-019375-30-GB
(EUCTR)
26/11/201003/08/2010A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura. A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura. Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 14.1;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: Anti-von Willebrand Factor Nanobody, INN = Caplacizumab
Product Code: ALX-0081
Other descriptive name: Anti-von Willebrand Factor Nanobody
AblynxNULLNot Recruiting Female: yes
Male: yes
115 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Belgium;Austria;Israel;Russian Federation;Germany;Italy;Switzerland;United Kingdom
64EUCTR2010-019375-30-DE
(EUCTR)
25/11/201016/08/2010A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura. Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 17.0;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: Anti-von Willebrand Factor Nanobody, Caplacizumab
Product Code: ALX-0081
Other descriptive name: Anti-von Willebrand Factor Nanobody
AblynxNULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;Canada;Spain;Belgium;Austria;Russian Federation;Israel;Germany;Italy;United Kingdom;Switzerland
65EUCTR2010-019375-30-IT
(EUCTR)
13/10/201009/11/2010A Phase II, single-blind, randomised, placebo-controlled trial to study the efficacy and safetyof anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients withacquired thrombotic thrombocytopenic purpura - NDA Phase II, single-blind, randomised, placebo-controlled trial to study the efficacy and safetyof anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients withacquired thrombotic thrombocytopenic purpura - ND Acquired Thrombotic Thrombocytopenic Purpura (TTP).This population includes symptomatic patients with acute episodes of idiopathic TTP as wellas secondary TTP syndrome in association with clinical conditions or medicinal products (denovo and recurrent symptoms) requiring treatment with plasma exchange.
MedDRA version: 9.1;Level: LLT;Classification code 10043648
MedDRA version: 9.1;Level: PT;Classification code 10043648
Product Name: Anti-von Willebrand Factor Nanobody
Product Code: ALX-0081
ABLYNX N.V.NULLNot RecruitingFemale: yes
Male: yes
110Phase 2Spain;Belgium;Austria;Germany;United Kingdom;Italy
66EUCTR2010-019375-30-BE
(EUCTR)
07/09/201003/05/2010A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura. Acquired thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 16.0;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: Anti-von Willebrand Factor Nanobody, INN = Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: Anti-von Willebrand Factor Nanobody
AblynxNULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;Spain;Belgium;Austria;Australia;Israel;Germany;Italy;United Kingdom;Switzerland
67NCT00907751
(ClinicalTrials.gov)
May 201022/5/2009Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic PurpuraAssociation of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: rituximabAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth12Phase 2France
68EUCTR2010-018794-38-IT
(EUCTR)
23/02/201026/07/2010EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTPEVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP THROMBOTIC THROMBOCYTOPENIC PURPURA
MedDRA version: 9.1;Level: LLT;Classification code 10037562
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
69NCT00799773
(ClinicalTrials.gov)
April 200926/11/2008Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)STAR - Study of TTP and Rituximab, A Randomized Clinical TrialThrombotic Thrombocytopenic PurpuraDrug: Rituximab;Procedure: Plasma exchange;Drug: CorticosteroidsNew England Research InstitutesNational Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc.Terminated12 YearsN/AAll3Phase 3United States
70NCT00726544
(ClinicalTrials.gov)
December 200830/7/2008Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic MicroangiopathyA Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic MicroangiopathyThrombotic Microangiopathy;Thrombotic Thrombocytopenic PurpuraDrug: ARC 1779 Placebo;Drug: ARC1779 InjectionArchemix Corp.NULLTerminated18 Years75 YearsBoth100Phase 2United States;Austria;Canada;Italy;United Kingdom
71NCT00953771
(ClinicalTrials.gov)
October 20084/8/2009Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: DanazolIcahn School of Medicine at Mount SinaiBeth Israel Medical CenterTerminated18 YearsN/AAll8Phase 2United States
72NCT00531089
(ClinicalTrials.gov)
December 200717/9/2007Rituximab in Patients With Relapsed or Refractory TTP-HUSA Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic Syndrome (HUS)Thrombotic Thrombocytopenic Purpura;Hemolytic Uremic SyndromeDrug: RituximabHamilton Health Sciences CorporationCanadian Apheresis Group;Hoffmann-La Roche;McMaster UniversityRecruiting18 YearsN/ABoth60Phase 2Canada
73EUCTR2007-004371-19-AT
(EUCTR)
20/11/200712/12/2007A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function DisordersA Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders von Willebrand Factor- related platelet function disorders : thrombotic thrombocytopenic purpura(TTP) in remission, acute TTP, and von Willebrand Disease Type- 2b (vWD-2b).
MedDRA version: 9.1;Level: LLT;Classification code 10037563;Term: Purpura thrombopenic thrombotic
MedDRA version: 9.1;Classification code 10047715;Term: Von Willebrand's disease
Product Name: ARC1779 Injection
Product Code: ARC1779
Other descriptive name: ARC 1779
Trade Name: Octostim
Product Name: desmopressin acetate
Product Code: desmopressin acetate
INN or Proposed INN: desmopressin acetate
Trade Name: Minirin
Product Name: desmopressin
Product Code: desmopressin
INN or Proposed INN: desmopressin acetate
Product Name: ARC1779 Injection
Product Code: ARC1779
Other descriptive name: ARC 1779
Archemix Corp.NULLNot RecruitingFemale: yes
Male: yes
28Phase 2Austria
74NCT00713193
(ClinicalTrials.gov)
November 20079/7/2008Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP)Thrombotic Thrombocytopenic PurpuraDrug: Cyclosporine;Drug: PrednisoneOhio State UniversityFood and Drug Administration (FDA)Completed18 YearsN/AAll16Phase 3United States
75NCT00411801
(ClinicalTrials.gov)
May 200713/12/2006Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)Thrombotic Thrombocytopenic Purpura (TTP)Biological: Uniplas;Biological: Cryosupernatant plasmaOctapharmaNULLTerminated18 YearsN/AAll8Phase 3United States
76NCT00937131
(ClinicalTrials.gov)
March 20069/7/2009The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP)A Study to Assess the Safety, Efficacy and Tolerability of Rituximab (Mabthera) in Combination With Plasma Exchange (PEX) in Patients With Acute Thrombotic Thrombocytopenic Purpura (TTP)Thrombotic Thrombocytopenic Purpura (TTP)Drug: RituximabUniversity College, LondonNULLActive, not recruiting18 Years65 YearsBoth40Phase 2United Kingdom
77EUCTR2005-002274-30-GB
(EUCTR)
14/12/200504/11/2005A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura.A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura. Thrombotic Thrombocytopenia PurpuraTrade Name: MabThera
Product Name: MabThera
Product Code: IDEC-C2B8, Ro 45-2294
University College LondonNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):United Kingdom
78NCT00251277
(ClinicalTrials.gov)
November 20057/11/2005Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic PurpuraUse of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: RituximabWeill Medical College of Cornell UniversityGenentech, Inc.Withdrawn17 YearsN/ABoth0Phase 1/Phase 2United States
79EUCTR2015-001098-42-IT
(EUCTR)
19/01/2021A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpuraA Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura - HERCULES 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] - Blood and lymphatic diseases [C15]
Product Name: Caplacizumab (an anti-von Willebrand Factor Nanobody)
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Product Name: Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Product Name: Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
ABLYNX NVNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Czechia;Spain;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
80EUCTR2016-001503-23-IT
(EUCTR)
18/01/2021Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES) - Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES) Acquired thrombotic thrombocytopenic purpura (TTP)
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: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081)
Product Code: ALX-0081
INN or Proposed INN: CAPLACIZUMAB
ABLYNX NVNULLNAFemale: yes
Male: yes
92Phase 3United States;Czechia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany
81EUCTR2017-000858-18-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
82EUCTR2020-003348-10-FR
(EUCTR)
25/01/2021A 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) 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 or BAX930 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 GmbHNULLNAFemale: yes
Male: yes
88Phase 3Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland
83EUCTR2015-001098-42-Outside-EU/EEA
(EUCTR)
16/10/2017A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. - HERCULES 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] - Blood and lymphatic diseases [C15]
Product Name: Caplacizumab
Product Code: ALX-0081
INN or Proposed INN: Caplacizumab
Other descriptive name: ALX-0081
Ablynx NVNULLNAFemale: yes
Male: yes
132Phase 3Switzerland;Turkey;United States;Australia;Canada;Israel
84EUCTR2017-000858-18-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
85EUCTR2020-003348-10-AT
(EUCTR)
28/01/2021A 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) 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 GmbHNULLNAFemale: yes
Male: yes
77Phase 3Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation
86EUCTR2020-003348-10-PL
(EUCTR)
16/02/2021A 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) 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
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
Baxalta Innovations GmbHNULLNAFemale: yes
Male: yes
88Phase 3Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Norway;Germany;Japan;Sweden