ALX-0081 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
64血栓性血小板減少性紫斑病26

64. 血栓性血小板減少性紫斑病


臨床試験数 : 92 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04074187
(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
2EUCTR2016-001503-23-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
3EUCTR2016-001503-23-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
4EUCTR2016-001503-23-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
5EUCTR2016-001503-23-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
6EUCTR2016-001503-23-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
7EUCTR2016-001503-23-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
8EUCTR2016-001503-23-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
9EUCTR2016-001503-23-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 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
10EUCTR2016-001503-23-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
11EUCTR2015-001098-42-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
12EUCTR2015-001098-42-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
13EUCTR2015-001098-42-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
14EUCTR2015-001098-42-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
15EUCTR2015-001098-42-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
16EUCTR2015-001098-42-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
17EUCTR2015-001098-42-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
18EUCTR2010-019375-30-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
19EUCTR2010-019375-30-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
20EUCTR2010-019375-30-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
21EUCTR2010-019375-30-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
22EUCTR2010-019375-30-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
23EUCTR2010-019375-30-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
24EUCTR2015-001098-42-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
25EUCTR2016-001503-23-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
26EUCTR2015-001098-42-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