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 : 92 / 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
| 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 | EUCTR2022-001177-31-DE (EUCTR) | 15/09/2022 | 29/06/2022 | Caplacizumab and immunosuppressive therapy without first line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura | An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura | 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] | Trade Name: Cablivi® Product Name: Cablivi® Product Code: ALX0081 INN or Proposed INN: Caplacizumab Other descriptive name: Nanobody directed towards the human A1 domain of von Willebrand factor Trade Name: Cablivi® Product Name: Cablivi® Product Code: ALX0081 INN or Proposed INN: Caplacizumab Other descriptive name: Nanobody directed towards the human A1 domain of von Willebrand factor | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Czechia;Greece;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Germany;Netherlands;Japan | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | EUCTR2010-019375-30-ES (EUCTR) | 10/02/2011 | 17/11/2010 | 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.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 | Ablynx | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 2 | Germany;United Kingdom;Belgium;Spain;Italy;Austria | |||
| 17 | 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 |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | EUCTR2010-019375-30-IT (EUCTR) | 13/10/2010 | 09/11/2010 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Spain;Belgium;Austria;Germany;United Kingdom;Italy | ||
| 22 | 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 | ||
| 23 | EUCTR2007-004371-19-AT (EUCTR) | 20/11/2007 | 12/12/2007 | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Austria | ||
| 24 | 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 | |||
| 25 | 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 |