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 | NCT05714969 (ClinicalTrials.gov) | March 21, 2023 | 24/1/2023 | A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) | A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in the Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) | Thrombotic Thrombocytopenic Purpura (TTP) | Biological: TAK-755 | Takeda | Takeda Development Center Americas, Inc. | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 2 | NULL |
| 2 | EUCTR2022-001940-36-ES (EUCTR) | 13/02/2023 | 22/12/2022 | A Phase 2b study of TAK-755 (rADAMTS13) with minimal to no PEX in the treatment of patients with iTTP | A Phase 2b, multicenter, randomized, double-blind study of safety and efficacy of TAK-755 (rADAMTS13) with minimal to no plasma exchange (PEX) in the treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP) | immune-mediated thrombotic thrombocytopenic purpura (iTTP) MedDRA version: 20.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: TAK-755 INN or Proposed INN: Apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Argentina;United States;United Kingdom;Switzerland;Spain;Greece;Canada;Austria;Poland;Italy;Israel;France;Germany | ||
| 3 | NCT05468320 (ClinicalTrials.gov) | November 21, 2022 | 18/7/2022 | Caplacizumab and Immunosuppressive Therapy Without Firstline 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 Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Drug: Caplacizumab;Drug: Corticosteroids;Biological: anti-CD20 antibody | Sanofi | NULL | Recruiting | 18 Years | 80 Years | All | 61 | Phase 3 | United States;Belgium;Czechia;France;Germany;Netherlands;Spain;United Kingdom |
| 4 | NCT05568147 (ClinicalTrials.gov) | October 1, 2022 | 25/9/2022 | Aspirin for Prophylaxis of TTP | A Prospective Multicenter Clinical Study of Aspirin for Prophylaxis in Patients With Hereditary or Acquired Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Drug: Aspirin tablet;Drug: Placebo | The First Affiliated Hospital of Soochow University | NULL | Not yet recruiting | N/A | N/A | All | 100 | Phase 2/Phase 3 | NULL |
| 5 | 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 | ||
| 6 | NCT05263193 (ClinicalTrials.gov) | June 8, 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 | Completed | N/A | 18 Years | All | 4 | France | |
| 7 | EUCTR2020-003348-10-IT (EUCTR) | 15/02/2022 | 01/12/2021 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) - TAK-755-3002 | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: [TAK-755 orBAX930 or SHP655] INN or Proposed INN: Apadamtase alfa INN or Proposed INN: Apadamtase alfa | BAXALTA INNOVATIONS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 77 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 8 | NCT05135442 (ClinicalTrials.gov) | December 1, 2021 | 6/11/2021 | Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP | The Efficacy and Safety of Bortezomib as First-line Treatment for Acquired Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura, Acquired | Drug: Bortezomib Injection | Peking Union Medical College Hospital | NULL | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | China |
| 9 | EUCTR2020-003348-10-AT (EUCTR) | 10/05/2021 | 28/01/2021 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 orBAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 77 | Phase 3 | Serbia;Portugal;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Norway;Germany;Japan;Sweden | ||
| 10 | 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 |
| 11 | NCT04683003 (ClinicalTrials.gov) | April 14, 2021 | 10/12/2020 | A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura | A Phase 3b, Prospective, Open-label, Multicenter, Single Treatment Arm, Continuation Study of the Safety and Efficacy of TAK-755 (rADAMTS13, Also Known as BAX 930/SHP655) in the Prophylactic and On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP; Upshaw-Schulman Syndrome, or Hereditary Thrombotic Thrombocytopenic Purpura) | Thrombotic Thrombocytopenic Purpura (TTP) | Biological: TAK-755 | Takeda | Takeda Development Center Americas, Inc.;Shire | Recruiting | N/A | 70 Years | All | 77 | Phase 3 | United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom |
| 12 | 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 | |
| 13 | 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 | ||
| 14 | EUCTR2020-003348-10-GB (EUCTR) | 17/11/2020 | 14/09/2020 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) - Baxalta TAK-755-3002 Continuation study to 281102 | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 orBAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;Portugal;Serbia;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 15 | NCT04588194 (ClinicalTrials.gov) | November 1, 2020 | 30/1/2020 | Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia | Romiplostim in Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment for Immune Thrombocytopenia | Immune Thrombocytopenia;Thrombotic Thrombocytopenic Purpura | Drug: Romiplostim;Drug: Rituximab;Drug: Dexamethasone | David Gomez Almaguer | NULL | Recruiting | 16 Years | 90 Years | All | 12 | Phase 2 | Mexico |
| 16 | EUCTR2018-003775-35-IT (EUCTR) | 21/02/2020 | 29/01/2021 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - na | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: [SHP 655 (BAX 930)] INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | BAXALTA INNOVATIONS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 17 | 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 |
| 18 | JPRN-JapicCTI-194991 | 20/10/2019 | 08/10/2019 | A phase 3, randomized, controlled study of prophylactic and on-demand | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2 period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) | severe congenital thrombotic thrombocytopenicpurpura (cTTP, Upshaw-Schulman Syndrome [USS],hereditary thrombotic thrombocytopenic purpura [hTTP] | Intervention name : rADAMTS-13 INN of the intervention : - Dosage And administration of the intervention : BAX930 is to be reconstituted using all the amount of the accompanying water for reconstitution and injected or dripped slowly intravenously. Normally, 40 (+/-4) international units per kg of body weight is administered at intervals of 1 to 2 weeks or according to the patient's symptoms. The frequency of dosing and dose level can be increased or decreased as appropriate according to the patient's symptoms. Control intervention name : Standrd of Care treatment INN of the control intervention : - Dosage And administration of the control intervention : - | Baxalta now part of Shire(ICCC: IQVIA Services Japan K.K.) | NULL | recruiting | 0 | 70 | BOTH | 4 | Phase 3 | Japan, North America, Europe |
| 19 | EUCTR2018-003775-35-DE (EUCTR) | 18/10/2019 | 30/04/2019 | A Phase 2, randomized, placebo-controlled, double-blind study ofrADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovation GmbH | NULL | Not Recruiting | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 20 | EUCTR2017-000858-18-IT (EUCTR) | 16/10/2019 | 15/02/2018 | A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 | severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | BAXALTA INNOVATIONS GMBH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy | ||
| 21 | EUCTR2017-000858-18-DE (EUCTR) | 09/10/2019 | 31/08/2017 | A Phase 3, randomized, controlled study in the treatment of severe congenital thrombotic thrombocytopenic purpura, with BAX 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 or TAK755 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 or TAK755 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 or TAK755 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 3 | France;United States;Canada;Poland;Spain;Austria;Germany;Switzerland;United Kingdom;Italy;Japan | ||
| 22 | NCT03922308 (ClinicalTrials.gov) | October 9, 2019 | 5/4/2019 | Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics,Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment | Acquired Thrombotic Thrombocytopenic Purpura (aTTP) | Other: Placebo;Drug: SHP655;Other: Standard of Care | Shire | Takeda Development Center Americas, Inc. | Completed | 18 Years | 75 Years | All | 28 | Phase 2 | United States;Canada;France;Germany;Italy;Spain;United Kingdom |
| 23 | EUCTR2018-003775-35-GB (EUCTR) | 03/07/2019 | 13/02/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - Baxalta SHP655-201 | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Germany;Italy;United Kingdom | ||
| 24 | NCT04021173 (ClinicalTrials.gov) | July 2019 | 15/7/2019 | A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP) | A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP) | Acquired Thrombotic Thrombocytopenic Purpura | Drug: Anfibatide;Drug: Placebos | Lee's Pharmaceutical Limited | NULL | Not yet recruiting | 18 Years | N/A | All | 74 | Phase 2 | China |
| 25 | EUCTR2018-003775-35-ES (EUCTR) | 13/06/2019 | 11/06/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 26 | NCT03237819 (ClinicalTrials.gov) | May 27, 2018 | 13/6/2017 | Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care | Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial | Thrombotic Thrombocytopenic Purpura | Drug: Sulfate, Magnesium;Drug: Placebo - Concentrate | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 18 Years | N/A | All | 74 | Phase 3 | France |
| 27 | EUCTR2017-000858-18-AT (EUCTR) | 20/03/2018 | 05/12/2017 | A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 or TAK755 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Trade Name: Octaplas SD Product Name: Octaplas®LG INN or Proposed INN: Octaplas Other descriptive name: Pooled Plasma (Human), Solvent/Detergent Treated Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 or TAK755 INN or Proposed INN: apademtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 3 | France;United States;Canada;Poland;Spain;Austria;Germany;Switzerland;United Kingdom;Italy;Japan | ||
| 28 | NCT03369314 (ClinicalTrials.gov) | March 2, 2018 | 30/11/2017 | Observational Study of the Use of octaplasLG®. | Observational, Real-life Study of the Use of octaplasLG®. | Thrombotic Thrombocytopenic Purpura | Drug: octaplasLG® | Octapharma | NULL | Completed | N/A | N/A | All | 263 | France;New Caledonia | |
| 29 | EUCTR2017-000858-18-ES (EUCTR) | 27/11/2017 | 18/09/2017 | A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000013328;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy | ||
| 30 | NCT03393975 (ClinicalTrials.gov) | October 13, 2017 | 5/10/2017 | A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP) | A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]) | Thrombotic Thrombocytopenic Purpura (TTP) | Biological: BAX930;Biological: Standard of care | Baxalta now part of Shire | Takeda Development Center Americas, Inc. | Recruiting | 0 Years | 70 Years | All | 57 | Phase 3 | United States;Austria;France;Germany;Italy;Japan;Poland;Spain;Switzerland;United Kingdom |
| 31 | EUCTR2017-000858-18-GB (EUCTR) | 12/09/2017 | 14/07/2017 | A Phase 3, randomized, controlled study in the treatment of severe congenital thrombotic thrombocytopenic purpura, with BAX 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 68 | Phase 3 | United States;France;Canada;Poland;Spain;Austria;Germany;Switzerland;Japan;Italy;United Kingdom | ||
| 32 | EUCTR2017-001117-86-GB (EUCTR) | 25/07/2017 | 18/05/2018 | Elective rituximab in TTP | A phase IV, prospective, randomised single-blind UK multicentre non-inferiority trial of low-dose versus standard dose rituximab for prevention of relapses in acquired TTP - Elective rituximab in TTP | Acquired thrombotic thrombocytopenic purpura;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Mabthera Product Name: Mabthera | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 4 | United Kingdom | ||
| 33 | 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 | ||
| 34 | NCT01938404 (ClinicalTrials.gov) | June 6, 2017 | 2/9/2013 | Octaplas Adult TTP Trial | Post-Marketing Requirement Study to Evaluate the Safety and Efficacy of Octaplas™ in Patients With Thrombotic Thrombocytopenic Purpura With Special Emphasis on Monitoring the Occurrence of Thromboembolic Events | Thrombotic Thrombocytopenic Purpura | Biological: Octaplas;Drug: Standard Plasma | Octapharma | NULL | Terminated | 18 Years | N/A | All | 1 | United States | |
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | NCT02878603 (ClinicalTrials.gov) | October 6, 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;Other: Standard of Care | 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 |
| 41 | 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 | ||
| 42 | NCT02854059 (ClinicalTrials.gov) | September 2016 | 27/7/2016 | IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients | A Phase II Pilot Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients With Low ADAMTS13 Activity | Purpura, Thrombotic Thrombocytopenic | Biological: IdeS (0.25 mg/kg);Biological: IdeS (0.50 mg/kg) | Hansa Biopharma AB | University College London Hospitals | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United Kingdom |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | EUCTR2016-000249-30-GB (EUCTR) | 14/07/2016 | 19/05/2016 | IDES IN ASYMPTOMATIC TTP PATIENTS | A PHASE II PILOT STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACODYNAMICS AND PHARMACOKINETICS OF IDES IN ASYMPTOMATIC ANTIBODY-MEDIATED THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) PATIENTS WITH LOW ADAMTS13 ACTIVITY - IDES IN ASYMPTOMATIC ANTIBODY-MEDIATED TTP PATIENTS WITH LOW ADAMTS13 | Asymptomatic antibody-mediated thrombotic thrombocytopenic purpura (TTP) with low ADAMTS13 activity MedDRA version: 19.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HMED-IdeS Product Code: HMED-IdeS Other descriptive name: IdeS | Hansa Medical AB | NULL | Not Recruiting | Female: yes Male: yes | 6 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 |
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | EUCTR2012-003221-19-PL (EUCTR) | 31/03/2015 | 09/02/2015 | Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTP | BAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP | Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP) MedDRA version: 18.1;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 14 | Phase 1 | United States;Poland;Austria;Germany;United Kingdom;Japan;Switzerland | ||
| 55 | EUCTR2012-003221-19-DE (EUCTR) | 12/03/2015 | 07/12/2012 | Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTP | BAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP | Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP) MedDRA version: 18.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 14 | Phase 1 | United States;Poland;Austria;Germany;United Kingdom;Japan;Switzerland | ||
| 56 | EUCTR2014-001032-11-PL (EUCTR) | 22/10/2014 | 21/08/2014 | A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies. | A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. | Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP) MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: OMS721 INN or Proposed INN: not yet available Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Product Code: OMS721 INN or Proposed INN: not yet available Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody | Omeros Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Taiwan;Hong Kong;Thailand;Malaysia;Belgium;Poland;Singapore;Lithuania;Bulgaria;New Zealand;Italy | ||
| 57 | EUCTR2014-001032-11-BE (EUCTR) | 10/10/2014 | 25/06/2014 | A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies. | A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. | Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP) MedDRA version: 18.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: OMS721 INN or Proposed INN: not yet available Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody | Omeros Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Belarus;Hong Kong;Taiwan;Thailand;Turkey;Lithuania;United Kingdom;Italy;Switzerland;Belgium;Malaysia;Poland;Bulgaria;Germany;New Zealand | ||
| 58 | NCT02216084 (ClinicalTrials.gov) | September 30, 2014 | 12/8/2014 | Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP) | BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic Thrombocytopenic Purpura (TTP) | Hereditary Thrombotic Thrombocytopenic Purpura (TTP) | Drug: Recombinant ADAMTS13 | Baxalta now part of Shire | NULL | Completed | 12 Years | 65 Years | All | 16 | Phase 1 | United States;Austria;Germany;Japan;Poland;Switzerland;United Kingdom |
| 59 | EUCTR2014-001032-11-LT (EUCTR) | 30/09/2014 | 02/06/2014 | A study to investigate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of study drug OMS721 in adults with thromboticmicroangiopathies. | A Phase 2, uncontrolled, three-stage, dose-escalation cohort study toevaluate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. | Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS)- hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP) MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: OMS721 INN or Proposed INN: not yet available Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Product Code: OMS721 INN or Proposed INN: not yet available Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody | Omeros Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Taiwan;Hong Kong;Thailand;Poland;Malaysia;Belgium;Singapore;Lithuania;Bulgaria;New Zealand;Italy | ||
| 60 | JPRN-JMA-IIA00160 | 20/01/2014 | 16/01/2014 | Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura | Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Intervention type:DRUG. Intervention1:Rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:1st cycle Initiate infusion at a rate of 50 mg/hr. In the absence of adverse events such as allergic reaction or infusion reaction, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. Subsequent cycles If patients did not experience or experience grade 2 or less severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 100 mg/hr and increase infusion rate by 100 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. If patients experience grade 3 or more severe adverse events such as allergic reaction or infusion reaction during previous cycles, initiate infusion at a rate of 50 mg/hr and increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.. | Saitama Medical University , Department of General Internal Medicine, Yoshitaka Miyakawa | NULL | Completed | >=20 YEARS | <=79 YEARS | BOTH | 8 | Phase 2 | Japan |
| 61 | ChiCTR-ONRC-13003194 | 2013-07-01 | 2013-04-18 | The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura. | The multicetre clinical study of the diagnosis,treatment and prognosis evaluation in thrombotic thrombocytopenic purpura. | Thrombotic Thrombocytopenic Purpura | experimental group:rituximab;Control group:No intervention; | The First Affiliated Hospital Of Soochow University | NULL | Recruiting | 8 | 75 | Both | experimental group:70;Control group:30; | I (Phase 1 study) | China |
| 62 | EUCTR2012-003221-19-GB (EUCTR) | 05/02/2013 | 13/12/2012 | Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTP | BAX 930 (rADAMTS13) A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP | Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP) MedDRA version: 18.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 14 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Poland;Austria;Germany;Japan;United Kingdom | ||
| 63 | EUCTR2012-003221-19-AT (EUCTR) | 17/12/2012 | 12/11/2012 | Phase 1 clinical study to assess safety of single infusions of rADAMTS13 (BAX930) in humans and to evaluate distribution and elimination of rADAMTS13 (BAX930) from the human body after administration at 3 different dose levels in patients diagnosed with severe hereditary TTP | BAX 930 (rADAMTS13)A PHASE 1 PROSPECTIVE, UNCONTROLLED, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS IN HEREDITARY TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) - Phase 1 dose escalation, single dose, to assess safety and PK of BAX930 in hTTP | Subjects diagnosed with hereditary thrombotic thrombocytopenic purpura (TTP) MedDRA version: 18.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 14 | Phase 1 | United States;Poland;Austria;Germany;United Kingdom;Japan | ||
| 64 | NCT01754545 (ClinicalTrials.gov) | September 2012 | 12/12/2012 | Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura | Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura | Purpura, Thrombotic Thrombocytopenic | Drug: Octaplas infusion and placebo (group 1);Drug: Octaplas infusion and placebo (group 2) | St. Olavs Hospital | Norwegian University of Science and Technology | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 4 | Norway |
| 65 | NCT01554514 (ClinicalTrials.gov) | August 2012 | 8/3/2012 | Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura | Adjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 Deficiency | Thrombotic Thrombocytopenic Purpura | Biological: rituximab | Washington University School of Medicine | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States |
| 66 | 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 | |||
| 67 | 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 |
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | NCT00907751 (ClinicalTrials.gov) | May 2010 | 22/5/2009 | Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura | Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Drug: rituximab | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 12 | Phase 2 | France |
| 74 | EUCTR2010-018794-38-IT (EUCTR) | 23/02/2010 | 26/07/2010 | EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP | EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP | THROMBOTIC THROMBOCYTOPENIC PURPURA MedDRA version: 9.1;Level: LLT;Classification code 10037562 | Trade Name: MABTHERA INN or Proposed INN: Rituximab | FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 75 | NCT00799773 (ClinicalTrials.gov) | April 2009 | 26/11/2008 | Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) | STAR - Study of TTP and Rituximab, A Randomized Clinical Trial | Thrombotic Thrombocytopenic Purpura | Drug: Rituximab;Procedure: Plasma exchange;Drug: Corticosteroids | New England Research Institutes | National Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc. | Terminated | 12 Years | N/A | All | 3 | Phase 3 | United States |
| 76 | NCT00726544 (ClinicalTrials.gov) | December 2008 | 30/7/2008 | Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy | A Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy | Thrombotic Microangiopathy;Thrombotic Thrombocytopenic Purpura | Drug: ARC 1779 Placebo;Drug: ARC1779 Injection | Archemix Corp. | NULL | Terminated | 18 Years | 75 Years | Both | 100 | Phase 2 | United States;Austria;Canada;Italy;United Kingdom |
| 77 | NCT00953771 (ClinicalTrials.gov) | October 2008 | 4/8/2009 | Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP) | Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Drug: Danazol | Icahn School of Medicine at Mount Sinai | Beth Israel Medical Center | Terminated | 18 Years | N/A | All | 8 | Phase 2 | United States |
| 78 | NCT00531089 (ClinicalTrials.gov) | December 2007 | 17/9/2007 | Rituximab in Patients With Relapsed or Refractory TTP-HUS | A Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic Syndrome (HUS) | Thrombotic Thrombocytopenic Purpura;Hemolytic Uremic Syndrome | Drug: Rituximab | Hamilton Health Sciences Corporation | Canadian Apheresis Group;Hoffmann-La Roche;McMaster University | Recruiting | 18 Years | N/A | Both | 60 | Phase 2 | Canada |
| 79 | 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 | ||
| 80 | NCT00713193 (ClinicalTrials.gov) | November 2007 | 9/7/2008 | Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP) | A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura | Drug: Cyclosporine;Drug: Prednisone | Ohio State University | Food and Drug Administration (FDA) | Completed | 18 Years | N/A | All | 16 | Phase 3 | United States |
| 81 | NCT00411801 (ClinicalTrials.gov) | May 2007 | 13/12/2006 | Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP) | A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura (TTP) | Biological: Uniplas;Biological: Cryosupernatant plasma | Octapharma | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 3 | United States |
| 82 | NCT00937131 (ClinicalTrials.gov) | March 2006 | 9/7/2009 | The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP) | A Study to Assess the Safety, Efficacy and Tolerability of Rituximab (Mabthera) in Combination With Plasma Exchange (PEX) in Patients With Acute Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura (TTP) | Drug: Rituximab | University College, London | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 40 | Phase 2 | United Kingdom |
| 83 | EUCTR2005-002274-30-GB (EUCTR) | 14/12/2005 | 04/11/2005 | A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura. | A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura. | Thrombotic Thrombocytopenia Purpura | Trade Name: MabThera Product Name: MabThera Product Code: IDEC-C2B8, Ro 45-2294 | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 84 | NCT00251277 (ClinicalTrials.gov) | November 2005 | 7/11/2005 | Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura | Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura | Thrombotic Thrombocytopenic Purpura | Drug: Rituximab | Weill Medical College of Cornell University | Genentech, Inc. | Withdrawn | 17 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States |
| 85 | EUCTR2020-003348-10-PL (EUCTR) | 16/02/2021 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 orBAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 77 | Phase 3 | Serbia;Portugal;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Norway;Germany;Japan;Sweden | |||
| 86 | EUCTR2017-000858-18-PL (EUCTR) | 22/07/2019 | A Phase 3, randomized, controlled study in the treatment of severe congenital thrombotic thrombocytopenic purpura, with BAX 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 68 | Phase 3 | France;United States;Canada;Spain;Poland;Austria;Germany;Japan;Italy;United Kingdom;Switzerland | |||
| 87 | 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 | |||
| 88 | EUCTR2020-003348-10-FR (EUCTR) | 25/01/2021 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 or BAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 88 | Phase 3 | Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland | |||
| 89 | EUCTR2017-000858-18-FR (EUCTR) | 12/01/2018 | A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Poland;Spain;Austria;Germany;Japan;Italy;United Kingdom;Switzerland | |||
| 90 | EUCTR2020-003348-10-DE (EUCTR) | 30/09/2021 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) | congenital Thrombotic thrombocytopenic purpura (TTP) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 orBAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 77 | Phase 3 | Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | |||
| 91 | 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 | |||
| 92 | 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 |