64. 血栓性血小板減少性紫斑病 ［臨床試験数：35，薬物数：55（DrugBank：16），標的遺伝子数：13，標的パスウェイ数：50］
Searched query = "Thrombotic thrombocytopenic purpura", "Upshaw Schulman syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-194991 | 20/10/2019 | 5 November 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.) | Not Recruiting | 0 | 70 | BOTH | 4 | Phase 3 | Japan, North America, Europe | |
| 2 | NCT03922308 | October 9, 2019 | 4 November 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 | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States;France;Spain;United Kingdom | |
| 3 | NCT04074187 | September 26, 2019 | 14 October 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 | Recruiting | 18 Years | N/A | All | 18 | Phase 2/Phase 3 | Japan | |
| 4 | NCT04021173 | July 2019 | 29 July 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 | Not recruiting | 18 Years | N/A | All | 74 | Phase 2 | China | |
| 5 | NCT03369314 | March 2, 2018 | 6 May 2019 | Observational Study of the Use of octaplasLG®. | Observational, Real-life Study of the Use of octaplasLG®. | Thrombotic Thrombocytopenic Purpura | Drug: octaplasLG® | Octapharma | Recruiting | N/A | N/A | All | 100 | N/A | France;New Caledonia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03237819 | December 2017 | 16 December 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 | Not recruiting | 18 Years | N/A | All | 74 | Phase 3 | France | |
| 7 | EUCTR2017-000858-18-ES | 27/11/2017 | 12 March 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 thrombotic thrombocytopenic 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: apadamtase alfa Current Sponsor code: SHP655 (BAX930) Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1500- | Baxalta Innovations GmbH | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Switzerland;United Kingdom;Italy;Japan;Germany;Austria;Spain;Canada;United States;France | |||
| 8 | NCT03393975 | November 6, 2017 | 15 July 2019 | A Phase 3, Randomized, Controlled Study of Prophylactic and On-demand Treatment of cTTP With BAX 930 (rADAMTS13) | 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 Participants With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP) (Upshaw-Schulman Syndrome) | Congenital Thrombotic Thrombocytopenic Purpura | Biological: BAX930;Biological: Standard of care | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | N/A | 70 Years | All | 62 | Phase 3 | United Kingdom |
| 9 | EUCTR2017-001117-86-GB | 25/07/2017 | 11 June 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 Pharmaceutical Form: Concentrate for solution for infusion | University College London | Authorised | Female: yes Male: yes | 52 | Phase 4 | United Kingdom | |||
| 10 | NCT01938404 | June 6, 2017 | 22 October 2019 | 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 | Not recruiting | 18 Years | N/A | All | 1 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2017-000858-18-FR | 22 January 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 thrombotic thrombocytopenic 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: apadamtase alfa Current Sponsor code: SHP655 (BAX930) Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1500- Pharmaceutical Form: Solution for infusion Pharmaceutical Form: Solution for infusion Pharmaceutical Form: Powder for solution for injection | Baxalta Innovations GmbH | Not Available | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Austria;Germany;Japan;Italy;United Kingdom;Switzerland | ||||
| 12 | NCT02878603 | October 2016 | 18 December 2018 | 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 | Ablynx | Not recruiting | 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 | |
| 13 | NCT02854059 | September 2016 | 30 September 2019 | 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 | Not recruiting | 18 Years | N/A | All | 2 | Phase 2 | United Kingdom |
| 14 | EUCTR2016-001503-23-AT | 16/08/2016 | 10 September 2018 | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: CAPLACIZUMAB CAS Number: 915810-67-2 Current Sponsor code: ALX-0081 Other descriptive name: ALX-0081 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 11.1- | Ablynx NV | Authorised | 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 | |||
| 15 | EUCTR2016-000249-30-GB | 14/07/2016 | 12 September 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 Pharmaceutical Form: Solution for infusion Current Sponsor code: HMED-IdeS Other descriptive name: IdeS Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10- | Hansa Medical AB | Authorised | Female: yes Male: yes | Phase 2 | United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2015-001098-42-BE | 27/08/2015 | 13 November 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. | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Caplacizumab CAS Number: 915810-67-2 Current Sponsor code: ALX-0081 Other descriptive name: ALX-0081 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Intravenous use | Ablynx NV | 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 | |||
| 17 | EUCTR2014-001032-11-LT | 30/09/2014 | 28 February 2019 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Product Code: OMS721 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 185- | Omeros Corporation | Authorised | Female: yes Male: yes | 89 | Phase 2 | United States;Hong Kong;Taiwan;Poland;Malaysia;Belgium;Thailand;Singapore;Lithuania;Bulgaria;New Zealand;Italy | |||
| 18 | JPRN-JMA-IIA00160 | 20/01/2014 | 2 April 2019 | 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 | Not Recruiting | >=20 YEARS | <=79 YEARS | BOTH | 8 | Phase 2 | Japan | |
| 19 | ChiCTR-ONRC-13003194 | 2013-07-01 | 18 April 2017 | 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 | Recruiting | 8 | 75 | Both | experimental group:70;Control group:30; | Phase 1 study | China | |
| 20 | EUCTR2012-003221-19-AT | 17/12/2012 | 11 April 2016 | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Current Sponsor code: BAX930 Concentration unit: IU/kg international unit(s)/kilogram Concentration type: up to Concentration number: 40- | Baxalta Innovations GmbH | Not Recruiting | Female: yes Male: yes | 14 | Phase 1 | United States;Poland;Austria;Germany;United Kingdom;Japan | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01754545 | September 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 0 | Phase 4 | Norway |
| 22 | NCT01554514 | August 2012 | 14 October 2019 | 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) | Not recruiting | 18 Years | N/A | All | 19 | Phase 2 | United States |
| 23 | EUCTR2010-019375-30-BE | 07/09/2010 | 21 August 2017 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Caplacizumab CAS Number: 915810- 67-2 Current Sponsor code: ALX-0081 Nanobody Other descriptive name: Anti-von Willebrand Factor Nanobody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5.0- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Ablynx | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | Switzerland;United Kingdom;Italy;Germany;Israel;Australia;Austria;Belgium;Spain;United States | |||
| 24 | NCT00907751 | May 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 12 | Phase 2 | France | |
| 25 | EUCTR2010-018794-38-IT | 23/02/2010 | 10 February 2014 | 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 | Pharmaceutical Form: Concentrate for solution for injection Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: MABTHERA Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Rituximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | Authorised | Female: yes Male: yes | Italy | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT00799773 | April 2009 | 19 October 2017 | 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. | Not recruiting | 12 Years | N/A | All | 3 | Phase 3 | United States |
| 27 | NCT00726544 | December 2008 | 19 February 2015 | 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. | Not recruiting | 18 Years | 75 Years | Both | 100 | Phase 2 | United States;Austria;Canada;Italy;United Kingdom | |
| 28 | NCT00953771 | October 2008 | 18 December 2018 | 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 | Not recruiting | 18 Years | N/A | All | 8 | Phase 2 | United States |
| 29 | NCT00531089 | December 2007 | 19 February 2015 | 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 |
| 30 | EUCTR2007-004371-19-AT | 20/11/2007 | 19 March 2012 | 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 Level: LLT Classification code 10047715 Term: Von Willebrand's disease | Product Name: ARC1779 Injection Product Code: ARC1779 Pharmaceutical Form: Solution for injection Current Sponsor code: ARC1779 Other descriptive name: ARC 1779 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Octostim Product Name: desmopressin acetate Product Code: desmopressin acetate Pharmaceutical Form: Solution for injection INN or Proposed INN: desmopressin acetate Current Sponsor code: desmopressin acetate Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Minirin Product Name: desmopressin Product Code: desmopressin Pharmaceutical Form: Solution for injection INN or Proposed INN: desmopressin acetate Current Sponsor code: desmopressin acetate Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Product Name: ARC1779 Injection Product Code: ARC1779 Pharmaceutical Form: Solution for injection Current Sponsor code: ARC1779 Other descriptive name: ARC 1779 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Archemix Corp. | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Austria | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT00713193 | November 2007 | 16 December 2017 | 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) | Not recruiting | 18 Years | N/A | All | 16 | Phase 3 | United States |
| 32 | NCT00411801 | May 2007 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 8 | Phase 3 | United States | |
| 33 | NCT00937131 | March 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 40 | Phase 2 | United Kingdom | |
| 34 | EUCTR2005-002274-30-GB | 14/12/2005 | 18 April 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion | University College London | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 35 | NCT00251277 | November 2005 | 19 February 2015 | 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. | Not recruiting | 17 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States |