↑ 疾患リストへ ← 戻る

 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:15] 

Searched query = "Thrombotic thrombocytopenic purpura", "Upshaw-Schulman syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-19499120/10/20195 November 2019A phase 3, randomized, controlled study of prophylactic and on-demandA 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 Recruiting070BOTH4Phase 3Japan, North America, Europe
2NCT03922308October 9, 20194 November 2019Study 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) TreatmentAcquired Thrombotic Thrombocytopenic Purpura (aTTP)Other: Placebo;Drug: SHP655;Other: Standard of CareShireRecruiting18 Years75 YearsAll30Phase 2United States;France;Spain;United Kingdom
3NCT04074187September 26, 201914 October 2019A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: Caplacizumab (ALX-0081);Drug: Plasma exchange (PE);Drug: Corticosteroid treatment (Methylprednisolone or prednisolone);Drug: Immunosuppressive treatment (eg, rituximab)SanofiRecruiting18 YearsN/AAll18Phase 2/Phase 3Japan
4NCT04021173July 201929 July 2019A 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 PurpuraDrug: Anfibatide;Drug: PlacebosLee's Pharmaceutical LimitedNot recruiting18 YearsN/AAll74Phase 2China
5NCT03369314March 2, 20186 May 2019Observational Study of the Use of octaplasLG®.Observational, Real-life Study of the Use of octaplasLG®.Thrombotic Thrombocytopenic PurpuraDrug: octaplasLG®OctapharmaRecruitingN/AN/AAll100N/AFrance;New Caledonia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03237819December 201716 December 2017Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive CareInterest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled TrialThrombotic Thrombocytopenic PurpuraDrug: Sulfate, Magnesium;Drug: Placebo - ConcentrateAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll74Phase 3France
7EUCTR2017-000858-18-ES27/11/201712 March 2018A 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 930severe 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 GmbHNot RecruitingFemale: yes
Male: yes
60Phase 3Switzerland;United Kingdom;Italy;Japan;Germany;Austria;Spain;Canada;United States;France
8NCT03393975November 6, 201715 July 2019A 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 PurpuraBiological: BAX930;Biological: Standard of careBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/A70 YearsAll62Phase 3United Kingdom
9EUCTR2017-001117-86-GB25/07/201711 June 2018Elective rituximab in TTPA 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 TTPAcquired 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 LondonAuthorisedFemale: yes
Male: yes
52Phase 4United Kingdom
10NCT01938404June 6, 201722 October 2019Octaplas Adult TTP TrialPost-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 EventsThrombotic Thrombocytopenic PurpuraBiological: Octaplas;Drug: Standard PlasmaOctapharmaNot recruiting18 YearsN/AAll1Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-000858-18-FR22 January 2018A 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 930severe 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 GmbHNot AvailableFemale: yes
Male: yes
60Phase 3United States;France;Canada;Austria;Germany;Japan;Italy;United Kingdom;Switzerland
12NCT02878603October 201618 December 2018Follow-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 PurpuraBiological: caplacizumabAblynxNot recruiting18 YearsN/AAll104Phase 3United States;Austria;Belgium;Canada;Czechia;France;Hungary;Israel;Italy;Spain;Switzerland;Turkey;United Kingdom;Czech Republic
13NCT02854059September 201630 September 2019IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) PatientsA 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 ActivityPurpura, Thrombotic ThrombocytopenicBiological: IdeS (0.25 mg/kg);Biological: IdeS (0.50 mg/kg)Hansa Biopharma ABUniversity College London HospitalsNot recruiting18 YearsN/AAll2Phase 2United Kingdom
14EUCTR2016-001503-23-AT16/08/201610 September 2018Follow-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 NVAuthorisedFemale: yes
Male: yes
104Phase 3United States;Spain;Turkey;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany
15EUCTR2016-000249-30-GB14/07/201612 September 2016IDES IN ASYMPTOMATIC TTP PATIENTSA 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 ADAMTS13Asymptomatic 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 ABAuthorisedFemale: yes
Male: yes
Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-001098-42-BE27/08/201513 November 2017A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.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 NVNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand
17EUCTR2014-001032-11-LT30/09/201428 February 2019A 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 CorporationAuthorised Female: yes
Male: yes
89Phase 2United States;Hong Kong;Taiwan;Poland;Malaysia;Belgium;Thailand;Singapore;Lithuania;Bulgaria;New Zealand;Italy
18JPRN-JMA-IIA0016020/01/20142 April 2019Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic PurpuraInvestigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraIntervention 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 MiyakawaNot Recruiting>=20 YEARS<=79 YEARSBOTH8Phase 2Japan
19ChiCTR-ONRC-130031942013-07-0118 April 2017The 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 Purpuraexperimental group:rituximab;Control group:No intervention;The First Affiliated Hospital Of Soochow UniversityRecruiting875Bothexperimental group:70;Control group:30;Phase 1 studyChina
20EUCTR2012-003221-19-AT17/12/201211 April 2016Phase 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 TTPBAX 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 hTTPSubjects 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 GmbHNot RecruitingFemale: yes
Male: yes
14Phase 1United States;Poland;Austria;Germany;United Kingdom;Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01754545September 201219 February 2015Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic PurpuraProphylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic PurpuraPurpura, Thrombotic ThrombocytopenicDrug: Octaplas infusion and placebo (group 1);Drug: Octaplas infusion and placebo (group 2)St. Olavs HospitalNorwegian University of Science and TechnologyNot recruiting18 Years65 YearsBoth0Phase 4Norway
22NCT01554514August 201214 October 2019Low Dose Rituximab in Thrombotic Thrombocytopenic PurpuraAdjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 DeficiencyThrombotic Thrombocytopenic PurpuraBiological: rituximabWashington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 YearsN/AAll19Phase 2United States
23EUCTR2010-019375-30-BE07/09/201021 August 2017A 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
AblynxNot RecruitingFemale: yes
Male: yes
115Phase 2Switzerland;United Kingdom;Italy;Germany;Israel;Australia;Austria;Belgium;Spain;United States
24NCT00907751May 201019 February 2015Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic PurpuraAssociation of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: rituximabAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth12Phase 2France
25EUCTR2010-018794-38-IT23/02/201010 February 2014EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTPEVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTPTHROMBOTIC 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 MILANOAuthorisedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT00799773April 200919 October 2017Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)STAR - Study of TTP and Rituximab, A Randomized Clinical TrialThrombotic Thrombocytopenic PurpuraDrug: Rituximab;Procedure: Plasma exchange;Drug: CorticosteroidsNew England Research InstitutesNational Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc.Not recruiting12 YearsN/AAll3Phase 3United States
27NCT00726544December 200819 February 2015Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic MicroangiopathyA Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic MicroangiopathyThrombotic Microangiopathy;Thrombotic Thrombocytopenic PurpuraDrug: ARC 1779 Placebo;Drug: ARC1779 InjectionArchemix Corp.Not recruiting18 Years75 YearsBoth100Phase 2United States;Austria;Canada;Italy;United Kingdom
28NCT00953771October 200818 December 2018Safety 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 PurpuraThrombotic Thrombocytopenic PurpuraDrug: DanazolIcahn School of Medicine at Mount SinaiBeth Israel Medical CenterNot recruiting18 YearsN/AAll8Phase 2United States
29NCT00531089December 200719 February 2015Rituximab in Patients With Relapsed or Refractory TTP-HUSA 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 SyndromeDrug: RituximabHamilton Health Sciences CorporationCanadian Apheresis Group;Hoffmann-La Roche;McMaster UniversityRecruiting18 YearsN/ABoth60Phase 2Canada
30EUCTR2007-004371-19-AT20/11/200719 March 2012A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function DisordersA Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disordersvon 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 RecruitingFemale: yes
Male: yes
28Phase 2Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00713193November 200716 December 2017Study 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 PurpuraDrug: Cyclosporine;Drug: PrednisoneOhio State UniversityFood and Drug Administration (FDA)Not recruiting18 YearsN/AAll16Phase 3United States
32NCT00411801May 200716 December 2017Safety 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 plasmaOctapharmaNot recruiting18 YearsN/AAll8Phase 3United States
33NCT00937131March 200619 February 2015The 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: RituximabUniversity College, LondonNot recruiting18 Years65 YearsBoth40Phase 2United Kingdom
34EUCTR2005-002274-30-GB14/12/200518 April 2012A 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 PurpuraTrade Name: MabThera
Product Name: MabThera
Product Code: IDEC-C2B8, Ro 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
University College LondonAuthorisedFemale: yes
Male: yes
United Kingdom
35NCT00251277November 200519 February 2015Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic PurpuraUse of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: RituximabWeill Medical College of Cornell UniversityGenentech, Inc.Not recruiting17 YearsN/ABoth0Phase 1/Phase 2United States

先頭へ