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

  
31 trials found
No.TrialIDDate_
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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
2NCT04720261
(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
3NCT04985318
(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
4EUCTR2020-005288-30-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
5NCT04074187
(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
6EUCTR2016-001503-23-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
7EUCTR2016-001503-23-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
8EUCTR2016-001503-23-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
9EUCTR2016-001503-23-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
10EUCTR2016-001503-23-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
11EUCTR2016-001503-23-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
12EUCTR2016-001503-23-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
13NCT02878603
(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
14EUCTR2016-001503-23-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
15EUCTR2016-001503-23-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
16EUCTR2015-001098-42-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
17EUCTR2015-001098-42-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
18NCT02553317
(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
19EUCTR2015-001098-42-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
20EUCTR2015-001098-42-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
21EUCTR2015-001098-42-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
22EUCTR2015-001098-42-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
23EUCTR2015-001098-42-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
24NCT01151423
(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
25EUCTR2010-019375-30-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
26EUCTR2010-019375-30-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
27EUCTR2010-019375-30-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
28EUCTR2010-019375-30-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
29EUCTR2015-001098-42-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
30EUCTR2015-001098-42-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
31EUCTR2016-001503-23-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