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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05263193 (ClinicalTrials.gov) | March 16, 2022 | 22/2/2022 | Retrospective 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 Caplacizumab | Immune-mediated Thrombocytopenic Purpura | Drug: Caplacizumab | Sanofi | NULL | Not yet recruiting | N/A | 18 Years | All | 30 | France | |
| 2 | NCT04720261 (ClinicalTrials.gov) | May 1, 2021 | 12/1/2021 | Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP | Efficacy 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, Acquired | Drug: Caplacizumab | University Hospital, Rouen | NULL | Not yet recruiting | 18 Years | 100 Years | All | 125 | Phase 2 | NULL |
| 3 | NCT04985318 (ClinicalTrials.gov) | March 25, 2021 | 21/7/2021 | Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP | Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020 | Acquired Thrombotic Thrombocytopenic Purpura | Drug: Cablivi® | University of Cologne | NULL | Recruiting | 18 Years | N/A | All | 350 | Germany | |
| 4 | EUCTR2020-005288-30-FR (EUCTR) | 28/12/2020 | 06/11/2020 | Efficacy 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 | Efficacy 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: CABLIVI | CHU de Rouen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 2 | France | ||
| 5 | NCT04074187 (ClinicalTrials.gov) | October 21, 2019 | 14/8/2019 | A 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 Purpura | Thrombotic Thrombocytopenic Purpura | Drug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab) | Sanofi | NULL | Completed | 18 Years | N/A | All | 21 | Phase 2/Phase 3 | Japan |
| 6 | EUCTR2016-001503-23-NL (EUCTR) | 05/07/2017 | 19/07/2017 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany | ||
| 7 | EUCTR2016-001503-23-DE (EUCTR) | 12/04/2017 | 03/01/2017 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany | ||
| 8 | EUCTR2016-001503-23-FR (EUCTR) | 07/02/2017 | 20/10/2016 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Australia;Germany;Netherlands | ||
| 9 | EUCTR2016-001503-23-GB (EUCTR) | 15/11/2016 | 15/08/2016 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 3 | United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany | ||
| 10 | EUCTR2016-001503-23-CZ (EUCTR) | 31/10/2016 | 19/08/2016 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 3 | Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;United States | ||
| 11 | EUCTR2016-001503-23-BE (EUCTR) | 21/10/2016 | 22/08/2016 | Follow-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 NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 104 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany | ||
| 12 | EUCTR2016-001503-23-HU (EUCTR) | 06/10/2016 | 10/08/2016 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands | ||
| 13 | NCT02878603 (ClinicalTrials.gov) | October 2016 | 4/8/2016 | Follow-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 | Biological: caplacizumab | Sanofi | NULL | Completed | 18 Years | N/A | All | 104 | Phase 3 | United States;Austria;Belgium;Canada;Czechia;France;Hungary;Israel;Italy;Spain;Switzerland;Turkey;United Kingdom;Czech Republic |
| 14 | EUCTR2016-001503-23-ES (EUCTR) | 25/08/2016 | 15/07/2016 | Follow-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 NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany | ||
| 15 | EUCTR2016-001503-23-AT (EUCTR) | 16/08/2016 | 14/07/2016 | Follow-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 NV | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany | ||
| 16 | EUCTR2015-001098-42-NL (EUCTR) | 11/04/2016 | 09/09/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;New Zealand | ||
| 17 | EUCTR2015-001098-42-DE (EUCTR) | 10/12/2015 | 04/08/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand | ||
| 18 | NCT02553317 (ClinicalTrials.gov) | November 2015 | 14/9/2015 | 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 | Biological: Caplacizumab;Biological: Placebo | Ablynx | NULL | Completed | 18 Years | N/A | All | 145 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;Switzerland;Turkey;United Kingdom;Czech Republic |
| 19 | EUCTR2015-001098-42-ES (EUCTR) | 29/10/2015 | 31/07/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand | ||
| 20 | EUCTR2015-001098-42-HU (EUCTR) | 15/10/2015 | 04/08/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany | ||
| 21 | EUCTR2015-001098-42-AT (EUCTR) | 06/10/2015 | 03/08/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany | ||
| 22 | EUCTR2015-001098-42-CZ (EUCTR) | 01/10/2015 | 29/07/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany | ||
| 23 | EUCTR2015-001098-42-BE (EUCTR) | 27/08/2015 | 13/07/2015 | A 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 NV | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand | ||
| 24 | NCT01151423 (ClinicalTrials.gov) | January 2011 | 25/6/2010 | Study 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 Purpura | Acquired Thrombotic Thrombocytopenic Purpura | Biological: Caplacizumab;Biological: Placebo | Ablynx | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;France;Germany;Israel;Italy;Romania;Spain;Switzerland;United Kingdom |
| 25 | EUCTR2010-019375-30-AT (EUCTR) | 07/12/2010 | 27/07/2010 | 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. | 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 | Ablynx | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | United States;Canada;Spain;Belgium;Austria;Israel;Russian Federation;Germany;Italy;United Kingdom;Switzerland | ||
| 26 | EUCTR2010-019375-30-GB (EUCTR) | 26/11/2010 | 03/08/2010 | 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. | 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 | Ablynx | NULL | Not 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): no | United States;Canada;Spain;Belgium;Austria;Israel;Russian Federation;Germany;Italy;Switzerland;United Kingdom | ||
| 27 | EUCTR2010-019375-30-DE (EUCTR) | 25/11/2010 | 16/08/2010 | 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. | 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 | Ablynx | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | United States;Canada;Spain;Belgium;Austria;Russian Federation;Israel;Germany;Italy;United Kingdom;Switzerland | ||
| 28 | EUCTR2010-019375-30-BE (EUCTR) | 07/09/2010 | 03/05/2010 | 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. | 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 | Ablynx | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | United States;Spain;Belgium;Austria;Australia;Israel;Germany;Italy;United Kingdom;Switzerland | ||
| 29 | EUCTR2015-001098-42-IT (EUCTR) | 19/01/2021 | A 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 (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 NV | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Czechia;Spain;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand | |||
| 30 | EUCTR2015-001098-42-Outside-EU/EEA (EUCTR) | 16/10/2017 | A 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 NV | NULL | NA | Female: yes Male: yes | 132 | Phase 3 | Switzerland;Turkey;United States;Australia;Canada;Israel | |||
| 31 | EUCTR2016-001503-23-IT (EUCTR) | 18/01/2021 | Follow-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 NV | NULL | NA | Female: yes Male: yes | 92 | Phase 3 | United States;Czechia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany |