↑ 疾患リストへ ← 戻る

 288. 自己免疫性後天性凝固因子欠乏症 [臨床試験数:84,薬物数:115(DrugBank:21),標的遺伝子数:7,標的パスウェイ数:7] 

Searched query = "Autoimmune acquired coagulation factor deficiency", "Coagulation factor deficiency", "Factor XIII deficiency", "Factor VIII deficiency", "Acquired hemophilia A", "von Willebrand Disease", "Factor V deficiency"
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
1NCT04119908January 20204 November 2019Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic DiseasesInterest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic DiseasesVon Willebrand Diseases;Glanzmann ThrombastheniaDevice: Sublingual videomicroscopy;Biological: blood sampleUniversity Hospital, LilleNot recruiting18 YearsN/AAll400N/A
2NCT04146376October 12, 20194 November 2019Von Willebrand Factor in Pregnancy (VIP) StudyVon Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for ChildbirthVon Willebrand DiseasesOther: Use of a postpartum diary and additional blood draws;Drug: VWF replacement therapy with Wilate;Drug: Tranexamic acid;Other: Use of a postpartum diary and additional blood draws.BloodworksMary M. Gooley Hemophilia Center;Ergomed;OctapharmaNot recruiting18 YearsN/AFemale110Phase 3United States
3NCT04106908October 201911 November 2019Effectiveness and Tolerability of Eqwilate in Real-life ConditionsMOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE StudyVWD - Von Willebrand's DiseaseBiological: EqwilateOctapharmaNot recruiting6 YearsN/AAll47Phase 1France
4NCT03879135April 1, 201929 April 2019rVWF Pediatric and Adult StudyA Phase 3b, Prospective, Open-label, Uncontrolled, Multicenter Study on Long-term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)Von Willebrand DiseaseBiological: rVWF;Biological: rFVIIIBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/AN/AAll64Phase 3United States
5NCT03782025February 13, 201926 August 2019Effect of Vitamin K in Critically Ill PatientsEffect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assaysCoagulation Factor Deficiency;Coagulopathy, Consumption;Vitamin K DeficiencyDrug: PhytomenadioneRegion SkaneRecruiting18 YearsN/AAll50Phase 2Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02606045February 7, 20191 July 2019Minimize Menorrhagia in Women With Type 1 Von Willebrand DiseaseProspective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Type 1 Von Willebrand Disease: The VWD Minimize StudyType 1 Von Willebrand DiseaseDrug: recombinant von Willebrand factor;Drug: tranexamic acidMargaret RagniUniversity of North Carolina;Duke UniversityRecruiting18 Years45 YearsFemale60Phase 3United States
7NCT03876301January 21, 201925 March 2019Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A ParticipantsA Multi-Center, Observational Study in Males With Hemophilia ABlood Coagulation Disorder;Blood Coagulation Disorders, Inherited;Coagulation Protein Disorders;Hemophilia A;Genetic Diseases, Inborn;Genetic Diseases, X-Linked;Hematologic Diseases;Hemorrhagic Disorders;Factor VIII DeficiencyDrug: Standard of Care FVIII Replacement therapySpark TherapeuticsRecruiting18 YearsN/AMale55Phase 3United States
8NCT03700229October 10, 20183 December 2018Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia AAn Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia AAcquired Hemophilia ADrug: Bortezomib;Drug: RituximabPeking Union Medical College HospitalRecruiting18 YearsN/AAll22Phase 2China
9NCT03634215August 15, 201827 August 2018Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in TraumaEstimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in TraumaMultiple Trauma;Coagulation Disorder;Coagulation Factor Deficiency;Coagulation Defect; AcquiredDiagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activityMasaryk Hospital Krajská zdravotní a.s.Not recruiting18 YearsN/AAll200N/A
10NCT03613584April 16, 20182 September 2019Von Willebrand Factor Concentrate During ECMO SupportA Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane OxygenationAcquired Von Willebrand DiseaseDrug: Von Willebrand Factor;Drug: Saline SolutionTirol Kiniken GmbHLFB BIOMEDICAMENTSRecruiting18 YearsN/AAll68Phase 2Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03006965March 2, 201810 December 2018Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian AlgorithmHemophilia A;Hemophilia;Factor VIII DeficiencyDrug: Octocog AlfaSpanish Society of Thrombosis and HaemostasisShire;Instituto de Investigación Hospital Universitario La PazRecruiting1 Year65 YearsMale100Phase 1Spain
12EUCTR2018-001631-46-NL28 February 2019Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand diseaseImplementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To WiNVon Willebrand disease
MedDRA version: 20.0 Level: LLT Classification code 10055168 Term: Von Willebrand's factor deficiency System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Minrin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Trade Name: Octostim
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Trade Name: Octostim
Pharmaceutical Form: Nasal spray
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Trade Name: Haemate P
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Trade Name: Wilate
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN COAGULATION FACTOR VIII
INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: Wilfactin
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Erasmus University Medical CenterNot Available Female: yes
Male: yes
120Phase 4Netherlands
13EUCTR2018-004675-13-BG30 April 2019Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease.CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD)Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
MedDRA version: 20.0 Level: LLT Classification code 10055168 Term: Von Willebrand's factor deficiency System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Wilate 500
Product Name: Wilate
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Current Sponsor code: WILATE
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Wilate 1000
Product Name: Wilate
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Current Sponsor code: WILATE
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
Octapharma AGNot Available Female: yes
Male: yes
28Phase 3Belarus;Hungary;Czech Republic;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
14NCT02973087December 22, 201711 June 2018rVWF IN PROPHYLAXISA PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASEVon Willebrand DiseaseBiological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)Baxalta now part of ShireRecruiting18 YearsN/AAll22Phase 3United States;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey
15NCT02932618December 18, 201713 May 2019BAX 111 rVWF in PediatricsA Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand DiseaseVon Willebrand DiseaseBiological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/A17 YearsAll39Phase 3United States;Austria;Belgium;Czechia;France;Italy;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-003036-37-AT27/10/201715 October 2018The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA double-blind, placebo-controlled pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Von Willebrand factor concentrate during ECMO supportVon Willebrand Disease (VWD)
MedDRA version: 20.0 Level: PT Classification code 10069495 Term: Acquired Von Willebrand's disease System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Natriumchlorid 0,9 %
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 9.0-
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000-
Tirol Kliniken GmbHAuthorisedFemale: yes
Male: yes
68Phase 2Austria
17NCT03384277October 26, 201722 October 2019Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabA Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabAcquired Hemophilia ADrug: Steroid;Drug: Rituximab;Drug: CyclophosphamideZhang LeiQilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer HospitalRecruiting18 Years80 YearsAll60Phase 3China
18EUCTR2016-000789-53-AT09/03/201721 August 2017The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Willfact during ECMOVon Willebrand Disease (VWD)
MedDRA version: 19.1 Level: PT Classification code 10069495 Term: Acquired Von Willebrand's disease System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Natriumchlorid 0,9 %
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 9.0-
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000-
Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische IntensivmedizinNot RecruitingFemale: yes
Male: yes
Phase 2Austria
19NCT03199794December 14, 201611 November 2019Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life PracticeProspective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life PracticeAcquired Hemophilia ABiological: OBIZURBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruiting18 YearsN/AAll50N/AAustria;Germany;Italy;Netherlands
20NCT01651468September 201616 December 2017The Effect of the Nutraceutical Hemofix on the Coagulation SystemPhase 1 Study of the Nutraceutical Hemofix Safety and Effect on the Coagulation SystemVon Willebrand Disease;MenorrhagiaDietary Supplement: HEMOFIXHadassah Medical OrganizationHEMOFIX;Yocheved Grossman;Idan GrossmanNot recruiting18 Years75 YearsAll0N/AIsrael
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02610127December 30, 201529 July 2019Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia APost-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia AAcquired Hemophilia ABiological: OBIZURBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireNot recruiting18 YearsN/AAll53Phase 1United States
22NCT02552576October 5, 201511 June 2018Study of Voncento® in Subjects With Von Willebrand DiseaseAn Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand DiseaseVon Willebrand DiseaseBiological: VoncentoCSL BehringNot recruitingN/AN/AAll26Phase 4Austria;Germany;Greece;Poland;United Kingdom;Ireland
23EUCTR2013-003305-25-GB07/07/201528 May 2018Study of Voncento® in Subjects with Von Willebrand DiseaseAn Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand DiseaseVon Willebrand Disease
MedDRA version: 18.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Voncento
Product Name: Voncento
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: Human Coagulation Factor VIII
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: Human Von Willebrand Factor
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1200-
Trade Name: Voncento
Product Name: Voncento
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: Human Coagulation Factor VIII
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
INN or Proposed INN: Human Von Willebrand Factor
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2400-
CSL Behring GmbHNot RecruitingFemale: yes
Male: yes
30Phase 4Germany;United Kingdom;Greece;Poland;Ireland;Austria
24NCT02283268April 1, 201516 December 2017Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing SurgeryA Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand DiseaseVon Willebrand DiseaseBiological: Recombinant von Willebrand Factor (rVWF)Baxalta now part of ShireNot recruiting18 YearsN/AAll24Phase 3United States;Australia;Austria;Czechia;Germany;Italy;Netherlands;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic
25NCT02979119June 201416 December 2017The European Paediatric Network for Haemophilia Management ( PedNet Registry)The European Paediatric Network for Haemophilia Management and the PedNet Haemophilia RegistryFactor VIII Deficiency;Factor IX DeficiencyDrug: Coagulation proteinsPedNet Haemophilia Research FoundationLund University HospitalRecruitingN/AN/AAll2200N/AAustria;Belgium;Canada;Denmark;Finland;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Spain;Sweden;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2014-005401-20-Outside-EU/EEA2 February 2015An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD)An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD)Von Willebrand's disease (VWD)
MedDRA version: 17.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Voncento, Biostate®
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
CSL LimitedNot AvailableFemale: yes
Male: yes
23Australia
27EUCTR2013-003240-23-IE09/12/20137 September 2015To compare the effectiveness of standard weight based dosing of Factor VIII prophylaxis against regimens using an individual's own rate of Factor VIII clearance in adult patients with severe Factor VIII deficiency (Haemophilia A).PERSONALising Factor VIII prophylaxis regimens: Efficacy of standard versus pharmacokinetically based regimens in adult patients with severe Haemophilia A (PERSONAL trial) - PERSONAL trialSevere Haemophilia A
MedDRA version: 14.1 Level: LLT Classification code 10018937 Term: Haemophilia A System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: ADVATE
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: OCTOCOG ALFA
CAS Number: 139076-62-3
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: range
Concentration number: 4000-10000
St. James' HospitalNot RecruitingFemale: no
Male: yes
Ireland
28NCT02472665December 201322 July 2019Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand DiseaseEvaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand DiseaseVon Willebrand DiseaseDrug: plasma-derived FVIII/VWF concentrateGrifols Therapeutics LLCInstituto Grifols, S.A.Recruiting2 Months6 YearsAll8Phase 4Spain
29EUCTR2012-003450-92-ES23/11/201323 December 2013Evaluation of the dynamic behavior, efficacy and safety of Fanhdi®, a high-purity von Willebrand containing FVIII concentrate, in pediatric patients with von Willebrand disease.EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWDSevere von Willebrand disease including types I, II, and III with VWF:RCof <15-20%
MedDRA version: 14.1 Level: PT Classification code 10068986 Term: Von Willebrand's factor activity decreased System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: LLT Classification code 10055168 Term: Von Willebrand's factor deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Fanhdi
Pharmaceutical Form: Concentrate and solvent for solution for injection
Instituto Grifols S.A.AuthorisedFemale: yes
Male: yes
8Spain
30NCT01968655September 201316 December 2017Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesExpanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNot recruiting18 YearsN/AAllN/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2010-023666-46-PL13/12/201122 October 2012A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERYEFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURESHAEMOPHILIA A
MedDRA version: 14.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: FACTANE 200 IU/ml
Product Code: F8VR
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 200-
LFB BIOTECHNOLOGIESNot RecruitingFemale: no
Male: yes
Poland
32NCT01410227November 201116 December 2017Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand DiseaseVon Willebrand DiseaseBiological: Recombinant von Willebrand factor (rVWF);Drug: Placebo;Biological: Recombinant factor VIIII (rFVIII)Baxalta now part of ShireNot recruiting18 Years65 YearsAll49Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Germany;India;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;France
33NCT01800435October 201119 February 2015A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With InhibitorWhole Blood Clot Stability and Thrombin Generating Capacity Following Treatment With Bypassing Agents (BPA) With and Without and Tranexamic Acid (TXA) in Haemophilia A Patients With inhibitor-an In-vivo Prospective Crossover StudyHereditary Factor VIII Deficiency Disease With InhibitorDrug: aPCC, aPCC + TXA;Drug: rFVIIa, rFVIIa + TXAOslo University HospitalNot recruiting18 Years65 YearsMale6Phase 4Norway
34NCT01365546June 201119 October 2017Wilate in Subjects With Von Willebrand Disease Who Undergo SurgeryProspective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical ProceduresPrevent Bleeding in Major SurgeryBiological: human VWF/FVIII concentrateOctapharmaNot recruiting6 YearsN/AAll30Phase 3United States;Bulgaria;India;Italy;Oman;Poland;Romania;South Africa;Turkey
35NCT01178294November 201016 December 2017Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesHemophilia ABiological: OBI-1Baxalta now part of ShireNot recruiting18 YearsN/AAll29Phase 2/Phase 3United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01224808October 201016 December 2017Extension Study of Biostate in Subjects With Von Willebrand DiseaseAn Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54Von Willebrand DiseaseBiological: BiostateCSL BehringNot recruitingN/AN/AAll20Phase 3Bulgaria;Germany;Poland;Russian Federation;Ukraine
37EUCTR2009-016869-28-GB20/09/201019 March 2012A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit DeficiencyA Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit DeficiencyCongenital FXIII A-subunit Deficiency
MedDRA version: 13.1 Level: PT Classification code 10016083 Term: Factor XIII deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Recombinant factor XIII (rFXIII)
Product Code: NN 1841
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Current Sponsor code: NN1841
Other descriptive name: Recombinant factor XIII (rFXIII)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Novo Nordisk A/SAuthorisedFemale: yes
Male: yes
Phase 3bUnited Kingdom
38EUCTR2010-020192-23-GB20/09/20104 August 2015A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760Congenital Factor XIII A-subunit Deficiency
MedDRA version: 17.0 Level: PT Classification code 10016083 Term: Factor XIII deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Recombinant factor XIII (rFXIII)
Product Code: NN1841
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Current Sponsor code: NN1841
Other descriptive name: Recombinant factor XIII (rFXIII)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes
6Sweden;United Kingdom;Italy;Germany;Austria;Denmark;Spain;Finland;France
39EUCTR2009-017753-34-DE09/07/201027 January 2014This clinical study investigates the effectiveness and safety of Biostate in children with von Willebrand’s disease (VWD), a blood clotting disorder. A two day investigation of the pharmacokinetics on 0,5, 4 8 12 24 and 48 h after administration (metabolism of Biostate by the child’s body) is a part of the investigation.A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease.Von Willebrand Disease
MedDRA version: 14.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Biostate
Pharmaceutical Form: Powder for injection
CAS Number: N/A
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250-
CAS Number: N/A
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 600-
Product Name: Biostate
Pharmaceutical Form: Powder for injection
CAS Number: N/A
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
CAS Number: N/A
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1200-
Product Name: Biostate
Pharmaceutical Form: Powder for injection
CAS Number: N/A
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
CAS Number: N/A
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2400-
CSL Behring GmbHNot RecruitingFemale: yes
Male: yes
12Phase 3Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany
40NCT00994929January 201019 October 2017Efficacy and Safety of IL-11 in DDAVP UnresponsivePhase II Biologic Effects Study of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Moderate or Mild Hemophilia A, or Von Willebrand Disease Unable to Use DDAVPHemophilia A;Von Willebrand DiseaseBiological: Neumega (Oprelvekin, Interleukin 11, IL-11)University of PittsburghNot recruiting18 YearsN/AAll9Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00978380September 21, 200929 January 2018Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNot recruiting6 YearsN/AAll63Phase 3United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom
42NCT00945906September 200919 October 2017An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human) (FXIII)CSL BehringNot recruitingN/AN/AAll61Phase 3United States
43EUCTR2008-007883-41-FI13/08/20097 December 2015A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2Congenital Factor XIII Deficiency
MedDRA version: 14.1 Level: PT Classification code 10061992 Term: Haemophilia System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: LLT Classification code 10010432 Term: Congenital deficiency of other clotting factors System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: HLT Classification code 10009735 Term: Coagulation disorders congenital System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Recombinant factor XIII (rFXIII)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Current Sponsor code: NN1841
Other descriptive name: Recombinant factor XIII (rFXIII)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes
60France;Finland;Spain;Austria;Germany;Italy;United Kingdom
44NCT00885742August 200919 October 2017A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNot recruitingN/AN/AAll41Phase 3United States;Spain
45NCT01994330June 200916 December 2017Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement SurgerySevere Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement SurgeryAcquired Von Willebrand Disease Secondary to Severe Aortic Stenosis;Heye´s Syndrome;Severe Aortic StenosisDrug: desmopressinPontificia Universidad Catolica de ChileFerring PharmaceuticalsNot recruitingN/AN/AAll13Phase 4Chile
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00883090May 200919 October 2017A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII DeficiencyA 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNot recruitingN/AN/AAll15Phase 2United States;Spain
47EUCTR2008-004922-18-BG16/04/20099 December 2013An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease.An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease.Von Willebrand Disease
MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease
MedDRA version: 9.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease
Product Name: Biostate®
Pharmaceutical Form: Powder and solvent for solution for infusion
Other descriptive name: von Willebrand Factor
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 1000-2000
Other descriptive name: Human Coagulation Factor VIII
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 500-1000
CSL Behring GmbHNot RecruitingFemale: yes
Male: yes
30Bulgaria
48EUCTR2008-008532-82-AT19/02/200919 March 2012A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2BA Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2Bvon Willebrand Disease type 2BProduct Name: ARC1779
Product Code: ARC1779
Pharmaceutical Form: Solution for infusion
Medical University of Vienna, Dept. of Clinical PharmacologyNot RecruitingFemale: yes
Male: yes
Austria
49EUCTR2007-004116-32-FR03/12/200819 March 2012EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NAEFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NASevere von Willebrand disease patients undergoing elective major surgery
MedDRA version: 9.1 Level: LLT Classification code 10055168 Term: Von Willebrand's factor deficiency
Trade Name: WILFACTIN
Product Name: WILFACTIN
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Human von Willebrand factor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
LFB BIOTECHNOLOGIESAuthorisedFemale: yes
Male: yes
18Belgium;France
50NCT00816660December 200816 December 2017Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand DiseaseRecombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)Von Willebrand DiseaseBiological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII);Biological: Marketed plasma-derived VWF/FVIII concentrateBaxalta now part of ShireNot recruiting18 Years60 YearsAll32Phase 1United States;Austria;Canada;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2008-000795-24-SE06/10/200829 January 2018Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOMESurveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOMEvon Willebrand diseaseTrade Name: Wilate
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: IU international unit(s)
Octapharma AGNot RecruitingFemale: yes
Male: yes
30Phase 4Sweden
52NCT00694785October 200819 February 2015A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2BA Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2BVon Willebrand DiseaseDrug: ARC1779Archemix Corp.Not recruiting16 Years75 YearsBoth2Phase 2
53EUCTR2006-003148-51-GB15/08/200819 March 2012A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725Congenital Factor XIII Deficiency
MedDRA version: 9.1 Level: LLT Classification code 10010432 Term: Congenital deficiency of other clotting factors
MedDRA version: 9.1 Level: LLT Classification code 10061992 Term: Haemophilia
MedDRA version: 9.1 Level: HLT Classification code 10009735 Term: Coagulation disorders congenital
Product Name: Recombinant Factor XIII (rFXIII)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Catridecacog
CAS Number: 606138-08-3
Current Sponsor code: NN1841
Other descriptive name: Recombinant Factor XIII (rFXIII)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Novo Nordisk A/SAuthorisedFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
54EUCTR2008-001910-25-SK17/07/200813 March 2017Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over studyPharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over studyInherited von Willebrand Disease (VWD) type 3
MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease
Trade Name: WILATE® 450
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 400VWF/450FVIII-
Trade Name: Haemate® P 250
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 600VWF/250FVIII-
Octapharma AGNot RecruitingFemale: yes
Male: yes
6Phase 2Slovakia
55NCT00524225February 200817 June 2019IL-11 in Adults With Von Willebrand Disease Undergoing SurgeryPhase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing SurgeryVon Willebrand DiseaseDrug: Neumega (Oprelvekin, Interleukin 11, IL-11)Margaret RagniUniversity of North Carolina;Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll3Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT00524342January 200816 December 2017IL-11 in Women With Von Willebrand Disease and Refractory MenorrhagiaPhase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory MenorrhagiaVon Willebrand DiseaseDrug: Oprelvekin, Interleukin 11, IL-11Margaret RagniUniversity of North Carolina;Wyeth is now a wholly owned subsidiary of PfizerNot recruiting18 Years45 YearsFemale7Phase 2United States
57NCT00632242January 200819 February 2015ARC1779 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 DisordersPurpura, Thrombotic Thrombocytopenic;Von Willebrand Disease Type-2bDrug: ARC1779Archemix Corp.Not recruiting18 Years75 YearsBoth28Phase 2Austria
58EUCTR2007-004371-19-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
59EUCTR2007-004943-31-SE03/10/200719 March 2012The VWD International Prophylaxis (VIP) Study - VIP studyThe VWD International Prophylaxis (VIP) Study - VIP studySevere form of von Willebrand diseaseTrade Name: Haemate-P, Wilate
Product Code: Factor VIII
Pharmaceutical Form: Intravenous infusion
Centre of Thrombosis and HaemostasisAuthorisedFemale: yes
Male: yes
200Sweden
60NCT00555555September 200723 April 2019Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand PatientsA Post-marketing Observation Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human,) Alphanate(R), in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand DiseaseVon Willebrand DiseaseBiological: Alphanate SD/HTGrifols Biologicals, LLCNot recruiting7 YearsN/AAll15Phase 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
61NCT00557908June 200716 December 2017The Von Willebrand Disease (VWD) International Prophylaxis StudyThe VWD International Prophylaxis (VIP) StudyVon Willebrand DiseaseDrug: VWF/FVIII productsSkane University HospitalBlood Center of Wisconsin;CSL BehringNot recruitingN/AN/AAll105N/AUnited States;Sweden
62NCT00404300February 200719 February 2015Optivate in People With Von Willebrand Disease Undergoing SurgeryAn Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate, in Patients With Von Willebrand Disease Who Are Undergoing SurgeryVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNot recruiting12 YearsN/ABoth25Phase 3Israel;United Kingdom
63EUCTR2006-000664-85-GB19/12/200619 March 2012An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having SurgeryAn Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgeryvon Willebrand diseaseTrade Name: Optivate
Product Name: Optivate
Product Code: N/A
Pharmaceutical Form: Powder and solvent for solution for injection
Bio Products LaboratoryAuthorisedFemale: yes
Male: yes
25United Kingdom
64EUCTR2006-002857-54-DE10/11/200619 March 2012International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)von Willebrand Jürgends syndrom in children under 6 years of ageTrade Name: WILATE
Product Name: Wiloctin
Octapharma AGNot RecruitingFemale: yes
Male: yes
50Germany
65NCT00387192November 200619 February 2015A Study With OPTIVATE® in People With Von Willebrand DiseaseAn Open Multi-centre Study in Patients With Von Willebrand Disease to Investigate the Pharmacokinetics, Efficacy and Safety of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor ConcentrateVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNot recruiting12 YearsN/ABoth26Phase 3Israel;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2006-000663-28-GB28/09/200619 March 2012An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands DiseaseAn open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands Diseasevon Willebrands DiseaseTrade Name: Optivate
Product Name: Optivate
Pharmaceutical Form: Powder and solvent for solution for injection
Bio Products LaboratoryAuthorisedFemale: yes
Male: yes
26United Kingdom
67EUCTR2006-001383-23-IT30/06/200629 August 2016Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILLEfficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILLpatients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings
MedDRA version: 8.1 Level: PT Classification code 10047715 Term: Von Willebrand's disease
Trade Name: ALPHANATE*INF 1F 1500UI+F 10ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: FANHDI*INF FL 250UI+SIR SOLV+S
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: ALPHANATE*INF 1F 500UI+F 5ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: ALPHANATE*INF 1F 1000UI+F 10ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 60-
Trade Name: FANHDI 250UI*1F 250UI+F 10ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Coagulation factor VIII
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMINot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
68EUCTR2005-004496-38-DK22/06/200619 March 2012Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy.Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy.von Willebrand disease (VWD) is an inherited bleeding disorder, characterised mainly by mucosal bleedings, which may be life-threatening, and joint bleeds in severe VWD cases. VWD is caused by a lack of von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Treatment of VWD aims at normalizing the VWF activity in plasma, which can be achieved by stimulating the endogenous release of VWF with desmopressin (DDAVP, 1-desamino-8-D arginine vasopressin) or by infusion of a VWF concentrate.Trade Name: Octostim
Product Name: Octostim
Product Code: DDAVP (Desmopressin)
Pharmaceutical Form: Intravenous infusion
Trade Name: Octostim
Product Name: Octostim
Product Code: DDAVP (Desmopressin)
Pharmaceutical Form: Nasal spray, solution
Rigshospitalet, CopenhagenNot RecruitingFemale: yes
Male: yes
150Denmark
69NCT00306670April 200619 October 2017Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia AA Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia AHemophilia ADrug: Rituxan;Drug: prednisoneGeorgetown UniversityGenentech, Inc.Not recruiting18 Years65 YearsAll2Phase 2/Phase 3United States
70EUCTR2005-001426-84-DE09/02/200619 March 2012CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASECLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASEInherited von Willebrand Disease
MedDRA version: 8.0 Level: PT Classification code 10047715
Trade Name: WILATE
Product Name: Wilate
Pharmaceutical Form: Powder and solvent for solution for injection
Octapharma AGNot RecruitingFemale: yes
Male: yes
20Czech Republic;Germany;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2006-000663-28-PL2 October 2017An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrateAn open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentratevon Willebrands Disease
MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease
Trade Name: Optivate
Product Code: N/A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Human coagulation factor VIII associated with von Willebrand factor (VWF)
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Bio Products LaboratoryNot AvailableFemale: yes
Male: yes
26Phase 3Poland;United Kingdom
72NCT00168077September 200519 February 2015Prothrombin Complex Concentrate for Anticoagulant ReversalEfficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral AnticoagulationAcquired Coagulation Factor DeficiencyDrug: Prothrombin Complex ConcentrateCSL BehringNot recruiting18 YearsN/ABoth40Phase 3Austria;Germany;Hungary;Israel;Lithuania;Netherlands;Poland;Switzerland
73EUCTR2004-004868-69-SE25/04/200519 March 2012Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with von Willebrand’s DiseaseStudy of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with von Willebrand’s DiseaseVon Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD.
MedDRA version: 7.1 Level: LLT Classification code 10047715
Trade Name: Humate-P
Product Name: Humate-P
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: VWF:RCo
Other descriptive name: Von Willebrand Factor Ristocetin Cofactor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 60-100
INN or Proposed INN: Factor VIII concentrate
Current Sponsor code: FVIII:C
Other descriptive name: Factor VIII concentrate
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 27-40
Current Sponsor code: VWF:Ag
Other descriptive name: Von Willebrand Factor Antigen
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 65-150
ZLB Behring LLCNot RecruitingFemale: yes
Male: yes
30Sweden
74EUCTR2004-005051-34-BE18/04/200517 August 2015Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLEEfficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLEVon Willebrand disease
Classification code 10047715
Trade Name: WILFACTIN
Product Name: WILFACTIN
Product Code: VWF SD-35-DH
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: human von Willebrand factor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 1-
LFB BIOTECHNOLOGIESNot RecruitingFemale: yes
Male: yes
15Belgium
75EUCTR2005-001746-17-BE13/04/200521 August 2017EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXISEFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXISvon Willebrand disease
Classification code 10047715
Trade Name: WILFACTIN
Product Name: WILFACTIN
Product Code: VWF SD-35-DH
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Human von Willebrand Factor
Current Sponsor code: vWF SD-35-DH
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100 -
LFB BIOTECHNOLOGIESNot RecruitingFemale: yes
Male: yes
6Phase 4Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2004-004868-69-AT07/03/200522 April 2013Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with von Willebrand’s DiseaseStudy of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with von Willebrand’s DiseaseVon Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD.
MedDRA version: 7.1 Level: LLT Classification code 10047715
Trade Name: Humate-P
Product Name: Humate-P
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: VWF:RCo
Other descriptive name: Von Willebrand Factor Ristocetin Cofactor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 60-100
INN or Proposed INN: Factor VIII concentrate
Current Sponsor code: FVIII:C
Other descriptive name: Factor VIII concentrate
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 27-40
Current Sponsor code: VWF:Ag
Other descriptive name: Von Willebrand Factor Antigen
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 65-150
ZLB Behring LLCNot RecruitingFemale: yes
Male: yes
30Austria;Sweden
77NCT02250508December 200426 February 2018A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.vonWillebrand's DiseaseBiological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII)Bio Products LaboratoryNot recruiting12 YearsN/AAllPhase 2Israel
78NCT00151125July 200430 May 2016Phase II Study of IL-11 (Neumega) in Von Willebrand DiseasePhase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand DiseaseVon Willebrand DiseaseDrug: recombinant interleukin-11University of PittsburghWyeth is now a wholly owned subsidiary of Pfizer;University of North CarolinaNot recruiting18 YearsN/ABoth12Phase 2United States
79NCT00056589March 200316 December 2017Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll DeficiencyA Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNot recruiting18 YearsN/AAll11Phase 1United States
80NCT00168090October 200119 February 2015Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.Von Willebrand Disease;Blood Coagulation Disorders;Blood Platelet Disorders;Hematologic DiseaseDrug: Blood coagulation Factor VIII and vWF, humanCSL BehringNot recruitingN/AN/ABoth30Phase 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
81NCT02246881October 200126 February 2018A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.Von Willebrand DiseaseBiological: Optivate® (Human Coagulation Factor VIII)Bio Products LaboratoryNot recruiting12 YearsN/AAllPhase 3Poland;United Kingdom
82NCT00111215January 200119 February 2015Treatment and Management of Women With Bleeding DisordersTreatment and Management of Women With Bleeding DisordersMenorrhagia;Blood Coagulation Disorders;Blood Platelet Disorders;Von Willebrand Disease;Hematologic DiseaseDrug: Tranexamic Acid;Drug: Desmopressin AcetateCenters for Disease Control and PreventionNot recruiting18 Years50 YearsFemale100N/AUnited States
83NCT00640289January 200019 February 2015Clinical Trial of Factor XIII (FXIII) ConcentrateClinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII DeficiencyHemophilia;Factor XIII DeficiencyDrug: Fibrogammin PChildren’s Hospital of Orange CountyCSL BehringNot recruitingN/AN/ABoth73N/AUnited States
84NCT00004667October 199319 February 2015Phase I Study of Human Von Willebrand Factor for Von Willebrand's DiseaseVon Willebrand's DiseaseDrug: von Willebrand factorNational Center for Research Resources (NCRR)University of North CarolinaNot recruitingN/AN/ABoth10Phase 1

先頭へ