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：10］
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 of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04119908 | January 2020 | 4 November 2019 | Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases | Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases | Von Willebrand Diseases;Glanzmann Thrombasthenia | Device: Sublingual videomicroscopy;Biological: blood sample | University Hospital, Lille | Not recruiting | 18 Years | N/A | All | 400 | N/A | ||
| 2 | NCT04146376 | October 12, 2019 | 4 November 2019 | Von Willebrand Factor in Pregnancy (VIP) Study | Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth | Von Willebrand Diseases | Other: 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. | Bloodworks | Mary M. Gooley Hemophilia Center;Ergomed;Octapharma | Not recruiting | 18 Years | N/A | Female | 110 | Phase 3 | United States |
| 3 | NCT04106908 | October 2019 | 11 November 2019 | Effectiveness and Tolerability of Eqwilate in Real-life Conditions | MOdalities 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 Study | VWD - Von Willebrand's Disease | Biological: Eqwilate | Octapharma | Not recruiting | 6 Years | N/A | All | 47 | Phase 1 | France | |
| 4 | NCT03879135 | April 1, 2019 | 29 April 2019 | rVWF Pediatric and Adult Study | A 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 Disease | Biological: rVWF;Biological: rFVIII | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | N/A | N/A | All | 64 | Phase 3 | United States |
| 5 | NCT03782025 | February 13, 2019 | 26 August 2019 | Effect of Vitamin K in Critically Ill Patients | Effect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assays | Coagulation Factor Deficiency;Coagulopathy, Consumption;Vitamin K Deficiency | Drug: Phytomenadione | Region Skane | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02606045 | February 7, 2019 | 1 July 2019 | Minimize Menorrhagia in Women With Type 1 Von Willebrand Disease | Prospective, 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 Study | Type 1 Von Willebrand Disease | Drug: recombinant von Willebrand factor;Drug: tranexamic acid | Margaret Ragni | University of North Carolina;Duke University | Recruiting | 18 Years | 45 Years | Female | 60 | Phase 3 | United States |
| 7 | NCT03876301 | January 21, 2019 | 25 March 2019 | Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants | A Multi-Center, Observational Study in Males With Hemophilia A | Blood Coagulation Disorder;Blood Coagulation Disorders, Inherited;Coagulation Protein Disorders;Hemophilia A;Genetic Diseases, Inborn;Genetic Diseases, X-Linked;Hematologic Diseases;Hemorrhagic Disorders;Factor VIII Deficiency | Drug: Standard of Care FVIII Replacement therapy | Spark Therapeutics | Recruiting | 18 Years | N/A | Male | 55 | Phase 3 | United States | |
| 8 | NCT03700229 | October 10, 2018 | 3 December 2018 | Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | Acquired Hemophilia A | Drug: Bortezomib;Drug: Rituximab | Peking Union Medical College Hospital | Recruiting | 18 Years | N/A | All | 22 | Phase 2 | China | |
| 9 | NCT03634215 | August 15, 2018 | 27 August 2018 | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma | Multiple Trauma;Coagulation Disorder;Coagulation Factor Deficiency;Coagulation Defect; Acquired | Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity | Masaryk Hospital Krajská zdravotní a.s. | Not recruiting | 18 Years | N/A | All | 200 | N/A | ||
| 10 | NCT03613584 | April 16, 2018 | 2 September 2019 | Von Willebrand Factor Concentrate During ECMO Support | A 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 | Acquired Von Willebrand Disease | Drug: Von Willebrand Factor;Drug: Saline Solution | Tirol Kiniken GmbH | LFB BIOMEDICAMENTS | Recruiting | 18 Years | N/A | All | 68 | Phase 2 | Austria |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03006965 | March 2, 2018 | 10 December 2018 | Pharmacokinetic 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 Algorithm | Hemophilia A;Hemophilia;Factor VIII Deficiency | Drug: Octocog Alfa | Spanish Society of Thrombosis and Haemostasis | Shire;Instituto de Investigación Hospital Universitario La Paz | Recruiting | 1 Year | 65 Years | Male | 100 | Phase 1 | Spain |
| 12 | EUCTR2018-001631-46-NL | 28 February 2019 | Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease | Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To WiN | Von 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 Center | Not Available | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||||
| 13 | EUCTR2018-004675-13-BG | 30 April 2019 | Study 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 AG | Not Available | Female: yes Male: yes | 28 | Phase 3 | Belarus;Hungary;Czech Republic;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||||
| 14 | NCT02973087 | December 22, 2017 | 11 June 2018 | rVWF IN PROPHYLAXIS | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE | Von Willebrand Disease | Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant) | Baxalta now part of Shire | Recruiting | 18 Years | N/A | All | 22 | Phase 3 | United States;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey | |
| 15 | NCT02932618 | December 18, 2017 | 13 May 2019 | BAX 111 rVWF in Pediatrics | A 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 Disease | Von Willebrand Disease | Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant) | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | N/A | 17 Years | All | 39 | Phase 3 | United States;Austria;Belgium;Czechia;France;Italy;Russian Federation;Spain;Turkey;Ukraine;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2017-003036-37-AT | 27/10/2017 | 15 October 2018 | The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine | A 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 support | Von 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 GmbH | Authorised | Female: yes Male: yes | 68 | Phase 2 | Austria | |||
| 17 | NCT03384277 | October 26, 2017 | 22 October 2019 | Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab | A Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab | Acquired Hemophilia A | Drug: Steroid;Drug: Rituximab;Drug: Cyclophosphamide | Zhang Lei | Qilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital | Recruiting | 18 Years | 80 Years | All | 60 | Phase 3 | China |
| 18 | EUCTR2016-000789-53-AT | 09/03/2017 | 21 August 2017 | The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine | A pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Willfact during ECMO | Von 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 Intensivmedizin | Not Recruiting | Female: yes Male: yes | Phase 2 | Austria | ||||
| 19 | NCT03199794 | December 14, 2016 | 11 November 2019 | Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice | Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice | Acquired Hemophilia A | Biological: OBIZUR | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | 18 Years | N/A | All | 50 | N/A | Austria;Germany;Italy;Netherlands |
| 20 | NCT01651468 | September 2016 | 16 December 2017 | The Effect of the Nutraceutical Hemofix on the Coagulation System | Phase 1 Study of the Nutraceutical Hemofix Safety and Effect on the Coagulation System | Von Willebrand Disease;Menorrhagia | Dietary Supplement: HEMOFIX | Hadassah Medical Organization | HEMOFIX;Yocheved Grossman;Idan Grossman | Not recruiting | 18 Years | 75 Years | All | 0 | N/A | Israel |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02610127 | December 30, 2015 | 29 July 2019 | Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A | Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A | Acquired Hemophilia A | Biological: OBIZUR | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Not recruiting | 18 Years | N/A | All | 53 | Phase 1 | United States |
| 22 | NCT02552576 | October 5, 2015 | 11 June 2018 | Study of Voncento® in Subjects With Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand Disease | Von Willebrand Disease | Biological: Voncento | CSL Behring | Not recruiting | N/A | N/A | All | 26 | Phase 4 | Austria;Germany;Greece;Poland;United Kingdom;Ireland | |
| 23 | EUCTR2013-003305-25-GB | 07/07/2015 | 28 May 2018 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von 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 GmbH | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | |||
| 24 | NCT02283268 | April 1, 2015 | 16 December 2017 | Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery | A 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 Disease | Von Willebrand Disease | Biological: Recombinant von Willebrand Factor (rVWF) | Baxalta now part of Shire | Not recruiting | 18 Years | N/A | All | 24 | Phase 3 | United States;Australia;Austria;Czechia;Germany;Italy;Netherlands;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic | |
| 25 | NCT02979119 | June 2014 | 16 December 2017 | The European Paediatric Network for Haemophilia Management ( PedNet Registry) | The European Paediatric Network for Haemophilia Management and the PedNet Haemophilia Registry | Factor VIII Deficiency;Factor IX Deficiency | Drug: Coagulation proteins | PedNet Haemophilia Research Foundation | Lund University Hospital | Recruiting | N/A | N/A | All | 2200 | N/A | Austria;Belgium;Canada;Denmark;Finland;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Spain;Sweden;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2014-005401-20-Outside-EU/EEA | 2 February 2015 | An 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 Limited | Not Available | Female: yes Male: yes | 23 | Australia | |||||
| 27 | EUCTR2013-003240-23-IE | 09/12/2013 | 7 September 2015 | To 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 trial | Severe 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' Hospital | Not Recruiting | Female: no Male: yes | Ireland | |||||
| 28 | NCT02472665 | December 2013 | 22 July 2019 | 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 Subjects With Severe Von Willebrand Disease | Von Willebrand Disease | Drug: plasma-derived FVIII/VWF concentrate | Grifols Therapeutics LLC | Instituto Grifols, S.A. | Recruiting | 2 Months | 6 Years | All | 8 | Phase 4 | Spain |
| 29 | EUCTR2012-003450-92-ES | 23/11/2013 | 23 December 2013 | Evaluation 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 VWD | Severe 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. | Authorised | Female: yes Male: yes | 8 | Spain | ||||
| 30 | NCT01968655 | September 2013 | 16 December 2017 | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | Not recruiting | 18 Years | N/A | All | N/A | United States | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2010-023666-46-PL | 13/12/2011 | 22 October 2012 | A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY | EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES | HAEMOPHILIA 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 BIOTECHNOLOGIES | Not Recruiting | Female: no Male: yes | Poland | |||||
| 32 | NCT01410227 | November 2011 | 16 December 2017 | Pharmacokinetics, 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 Disease | Von Willebrand Disease | Biological: Recombinant von Willebrand factor (rVWF);Drug: Placebo;Biological: Recombinant factor VIIII (rFVIII) | Baxalta now part of Shire | Not recruiting | 18 Years | 65 Years | All | 49 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Germany;India;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;France | |
| 33 | NCT01800435 | October 2011 | 19 February 2015 | A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor | Whole 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 Study | Hereditary Factor VIII Deficiency Disease With Inhibitor | Drug: aPCC, aPCC + TXA;Drug: rFVIIa, rFVIIa + TXA | Oslo University Hospital | Not recruiting | 18 Years | 65 Years | Male | 6 | Phase 4 | Norway | |
| 34 | NCT01365546 | June 2011 | 19 October 2017 | Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery | Prospective, 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 Procedures | Prevent Bleeding in Major Surgery | Biological: human VWF/FVIII concentrate | Octapharma | Not recruiting | 6 Years | N/A | All | 30 | Phase 3 | United States;Bulgaria;India;Italy;Oman;Poland;Romania;South Africa;Turkey | |
| 35 | NCT01178294 | November 2010 | 16 December 2017 | Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A | Efficacy 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-antibodies | Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | Not recruiting | 18 Years | N/A | All | 29 | Phase 2/Phase 3 | United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT01224808 | October 2010 | 16 December 2017 | Extension Study of Biostate in Subjects With Von Willebrand Disease | An 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-08-54 | Von Willebrand Disease | Biological: Biostate | CSL Behring | Not recruiting | N/A | N/A | All | 20 | Phase 3 | Bulgaria;Germany;Poland;Russian Federation;Ukraine | |
| 37 | EUCTR2009-016869-28-GB | 20/09/2010 | 19 March 2012 | A 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 Deficiency | A 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 Deficiency | Congenital 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/S | Authorised | Female: yes Male: yes | Phase 3b | United Kingdom | ||||
| 38 | EUCTR2010-020192-23-GB | 20/09/2010 | 4 August 2015 | A 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-3760 | A 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-3760 | Congenital 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/S | Not Recruiting | Female: yes Male: yes | 6 | Sweden;United Kingdom;Italy;Germany;Austria;Denmark;Spain;Finland;France | ||||
| 39 | EUCTR2009-017753-34-DE | 09/07/2010 | 27 January 2014 | This 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 GmbH | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany | |||
| 40 | NCT00994929 | January 2010 | 19 October 2017 | Efficacy and Safety of IL-11 in DDAVP Unresponsive | Phase 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 DDAVP | Hemophilia A;Von Willebrand Disease | Biological: Neumega (Oprelvekin, Interleukin 11, IL-11) | University of Pittsburgh | Not recruiting | 18 Years | N/A | All | 9 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT00978380 | September 21, 2009 | 29 January 2018 | Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 | A 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 | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | Not recruiting | 6 Years | N/A | All | 63 | Phase 3 | United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom | |
| 42 | NCT00945906 | September 2009 | 19 October 2017 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) (FXIII) | CSL Behring | Not recruiting | N/A | N/A | All | 61 | Phase 3 | United States | |
| 43 | EUCTR2008-007883-41-FI | 13/08/2009 | 7 December 2015 | A 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™2 | A 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™2 | Congenital 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/S | Not Recruiting | Female: yes Male: yes | 60 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||||
| 44 | NCT00885742 | August 2009 | 19 October 2017 | A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | Not recruiting | N/A | N/A | All | 41 | Phase 3 | United States;Spain | |
| 45 | NCT01994330 | June 2009 | 16 December 2017 | Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery | Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery | Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis;Heye´s Syndrome;Severe Aortic Stenosis | Drug: desmopressin | Pontificia Universidad Catolica de Chile | Ferring Pharmaceuticals | Not recruiting | N/A | N/A | All | 13 | Phase 4 | Chile |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00883090 | May 2009 | 19 October 2017 | A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency | A 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | Not recruiting | N/A | N/A | All | 15 | Phase 2 | United States;Spain | |
| 47 | EUCTR2008-004922-18-BG | 16/04/2009 | 9 December 2013 | An 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 GmbH | Not Recruiting | Female: yes Male: yes | 30 | Bulgaria | ||||
| 48 | EUCTR2008-008532-82-AT | 19/02/2009 | 19 March 2012 | A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B | A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B | von Willebrand Disease type 2B | Product Name: ARC1779 Product Code: ARC1779 Pharmaceutical Form: Solution for infusion | Medical University of Vienna, Dept. of Clinical Pharmacology | Not Recruiting | Female: yes Male: yes | Austria | |||||
| 49 | EUCTR2007-004116-32-FR | 03/12/2008 | 19 March 2012 | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | Severe 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 BIOTECHNOLOGIES | Authorised | Female: yes Male: yes | 18 | Belgium;France | ||||
| 50 | NCT00816660 | December 2008 | 16 December 2017 | Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease | Recombinant 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 Disease | Biological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII);Biological: Marketed plasma-derived VWF/FVIII concentrate | Baxalta now part of Shire | Not recruiting | 18 Years | 60 Years | All | 32 | Phase 1 | United States;Austria;Canada;Germany;Italy;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2008-000795-24-SE | 06/10/2008 | 29 January 2018 | Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME | Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME | von Willebrand disease | Trade Name: Wilate Pharmaceutical Form: Powder and solvent for solution for injection Concentration unit: IU international unit(s) | Octapharma AG | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Sweden | |||
| 52 | NCT00694785 | October 2008 | 19 February 2015 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B | Von Willebrand Disease | Drug: ARC1779 | Archemix Corp. | Not recruiting | 16 Years | 75 Years | Both | 2 | Phase 2 | ||
| 53 | EUCTR2006-003148-51-GB | 15/08/2008 | 19 March 2012 | A 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-1725 | A 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-1725 | Congenital 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/S | Authorised | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | ||||
| 54 | EUCTR2008-001910-25-SK | 17/07/2008 | 13 March 2017 | Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study | Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study | Inherited 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 AG | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Slovakia | |||
| 55 | NCT00524225 | February 2008 | 17 June 2019 | IL-11 in Adults With Von Willebrand Disease Undergoing Surgery | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery | Von Willebrand Disease | Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) | Margaret Ragni | University of North Carolina;Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 3 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT00524342 | January 2008 | 16 December 2017 | IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia | Von Willebrand Disease | Drug: Oprelvekin, Interleukin 11, IL-11 | Margaret Ragni | University of North Carolina;Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | 45 Years | Female | 7 | Phase 2 | United States |
| 57 | NCT00632242 | January 2008 | 19 February 2015 | ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function Disorders | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function Disorders | Purpura, Thrombotic Thrombocytopenic;Von Willebrand Disease Type-2b | Drug: ARC1779 | Archemix Corp. | Not recruiting | 18 Years | 75 Years | Both | 28 | Phase 2 | Austria | |
| 58 | EUCTR2007-004371-19-AT | 20/11/2007 | 19 March 2012 | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders | von Willebrand Factor- related platelet function disorders : thrombotic thrombocytopenic purpura(TTP) in remission, acute TTP, and von Willebrand Disease Type- 2b (vWD-2b). MedDRA version: 9.1 Level: LLT Classification code 10037563 Term: Purpura thrombopenic thrombotic MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease | Product Name: ARC1779 Injection Product Code: ARC1779 Pharmaceutical Form: Solution for injection Current Sponsor code: ARC1779 Other descriptive name: ARC 1779 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Octostim Product Name: desmopressin acetate Product Code: desmopressin acetate Pharmaceutical Form: Solution for injection INN or Proposed INN: desmopressin acetate Current Sponsor code: desmopressin acetate Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: Minirin Product Name: desmopressin Product Code: desmopressin Pharmaceutical Form: Solution for injection INN or Proposed INN: desmopressin acetate Current Sponsor code: desmopressin acetate Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Product Name: ARC1779 Injection Product Code: ARC1779 Pharmaceutical Form: Solution for injection Current Sponsor code: ARC1779 Other descriptive name: ARC 1779 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Archemix Corp. | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Austria | |||
| 59 | EUCTR2007-004943-31-SE | 03/10/2007 | 19 March 2012 | The VWD International Prophylaxis (VIP) Study - VIP study | The VWD International Prophylaxis (VIP) Study - VIP study | Severe form of von Willebrand disease | Trade Name: Haemate-P, Wilate Product Code: Factor VIII Pharmaceutical Form: Intravenous infusion | Centre of Thrombosis and Haemostasis | Authorised | Female: yes Male: yes | 200 | Sweden | ||||
| 60 | NCT00555555 | September 2007 | 23 April 2019 | Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients | A 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 Disease | Von Willebrand Disease | Biological: Alphanate SD/HT | Grifols Biologicals, LLC | Not recruiting | 7 Years | N/A | All | 15 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT00557908 | June 2007 | 16 December 2017 | The Von Willebrand Disease (VWD) International Prophylaxis Study | The VWD International Prophylaxis (VIP) Study | Von Willebrand Disease | Drug: VWF/FVIII products | Skane University Hospital | Blood Center of Wisconsin;CSL Behring | Not recruiting | N/A | N/A | All | 105 | N/A | United States;Sweden |
| 62 | NCT00404300 | February 2007 | 19 February 2015 | Optivate in People With Von Willebrand Disease Undergoing Surgery | An 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 | Von Willebrand Disease | Drug: Optivate | Bio Products Laboratory | Not recruiting | 12 Years | N/A | Both | 25 | Phase 3 | Israel;United Kingdom | |
| 63 | EUCTR2006-000664-85-GB | 19/12/2006 | 19 March 2012 | An 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 Surgery | An 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 Surgery | von Willebrand disease | Trade Name: Optivate Product Name: Optivate Product Code: N/A Pharmaceutical Form: Powder and solvent for solution for injection | Bio Products Laboratory | Authorised | Female: yes Male: yes | 25 | United Kingdom | ||||
| 64 | EUCTR2006-002857-54-DE | 10/11/2006 | 19 March 2012 | International 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 age | Trade Name: WILATE Product Name: Wiloctin | Octapharma AG | Not Recruiting | Female: yes Male: yes | 50 | Germany | ||||
| 65 | NCT00387192 | November 2006 | 19 February 2015 | A Study With OPTIVATE® in People With Von Willebrand Disease | An 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 | Von Willebrand Disease | Drug: Optivate | Bio Products Laboratory | Not recruiting | 12 Years | N/A | Both | 26 | Phase 3 | Israel;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2006-000663-28-GB | 28/09/2006 | 19 March 2012 | An 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 Disease | An 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 Disease | von Willebrands Disease | Trade Name: Optivate Product Name: Optivate Pharmaceutical Form: Powder and solvent for solution for injection | Bio Products Laboratory | Authorised | Female: yes Male: yes | 26 | United Kingdom | ||||
| 67 | EUCTR2006-001383-23-IT | 30/06/2006 | 29 August 2016 | Efficacy, 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.WILL | Efficacy, 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.WILL | patients 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 BONOMI | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | |||
| 68 | EUCTR2005-004496-38-DK | 22/06/2006 | 19 March 2012 | Desmopressin 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, Copenhagen | Not Recruiting | Female: yes Male: yes | 150 | Denmark | ||||
| 69 | NCT00306670 | April 2006 | 19 October 2017 | Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A | A 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 A | Hemophilia A | Drug: Rituxan;Drug: prednisone | Georgetown University | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | All | 2 | Phase 2/Phase 3 | United States |
| 70 | EUCTR2005-001426-84-DE | 09/02/2006 | 19 March 2012 | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | Inherited 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 AG | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Germany;France | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2006-000663-28-PL | 2 October 2017 | An 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 | An 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 | von 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 Laboratory | Not Available | Female: yes Male: yes | 26 | Phase 3 | Poland;United Kingdom | ||||
| 72 | NCT00168077 | September 2005 | 19 February 2015 | Prothrombin Complex Concentrate for Anticoagulant Reversal | Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation | Acquired Coagulation Factor Deficiency | Drug: Prothrombin Complex Concentrate | CSL Behring | Not recruiting | 18 Years | N/A | Both | 40 | Phase 3 | Austria;Germany;Hungary;Israel;Lithuania;Netherlands;Poland;Switzerland | |
| 73 | EUCTR2004-004868-69-SE | 25/04/2005 | 19 March 2012 | 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 | 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’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 LLC | Not Recruiting | Female: yes Male: yes | 30 | Sweden | ||||
| 74 | EUCTR2004-005051-34-BE | 18/04/2005 | 17 August 2015 | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Von 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 BIOTECHNOLOGIES | Not Recruiting | Female: yes Male: yes | 15 | Belgium | ||||
| 75 | EUCTR2005-001746-17-BE | 13/04/2005 | 21 August 2017 | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | von 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 BIOTECHNOLOGIES | Not Recruiting | Female: yes Male: yes | 6 | Phase 4 | Belgium | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2004-004868-69-AT | 07/03/2005 | 22 April 2013 | 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 | 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’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 LLC | Not Recruiting | Female: yes Male: yes | 30 | Austria;Sweden | ||||
| 77 | NCT02250508 | December 2004 | 26 February 2018 | A 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 Disease | Biological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII) | Bio Products Laboratory | Not recruiting | 12 Years | N/A | All | Phase 2 | Israel | ||
| 78 | NCT00151125 | July 2004 | 30 May 2016 | Phase II Study of IL-11 (Neumega) in Von Willebrand Disease | Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease | Von Willebrand Disease | Drug: recombinant interleukin-11 | University of Pittsburgh | Wyeth is now a wholly owned subsidiary of Pfizer;University of North Carolina | Not recruiting | 18 Years | N/A | Both | 12 | Phase 2 | United States |
| 79 | NCT00056589 | March 2003 | 16 December 2017 | Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency | A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | Not recruiting | 18 Years | N/A | All | 11 | Phase 1 | United States | |
| 80 | NCT00168090 | October 2001 | 19 February 2015 | Study 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 Disease | Drug: Blood coagulation Factor VIII and vWF, human | CSL Behring | Not recruiting | N/A | N/A | Both | 30 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT02246881 | October 2001 | 26 February 2018 | A 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 Disease | Biological: Optivate® (Human Coagulation Factor VIII) | Bio Products Laboratory | Not recruiting | 12 Years | N/A | All | Phase 3 | Poland;United Kingdom | ||
| 82 | NCT00111215 | January 2001 | 19 February 2015 | Treatment and Management of Women With Bleeding Disorders | Treatment and Management of Women With Bleeding Disorders | Menorrhagia;Blood Coagulation Disorders;Blood Platelet Disorders;Von Willebrand Disease;Hematologic Disease | Drug: Tranexamic Acid;Drug: Desmopressin Acetate | Centers for Disease Control and Prevention | Not recruiting | 18 Years | 50 Years | Female | 100 | N/A | United States | |
| 83 | NCT00640289 | January 2000 | 19 February 2015 | Clinical Trial of Factor XIII (FXIII) Concentrate | Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency | Hemophilia;Factor XIII Deficiency | Drug: Fibrogammin P | Children’s Hospital of Orange County | CSL Behring | Not recruiting | N/A | N/A | Both | 73 | N/A | United States |
| 84 | NCT00004667 | October 1993 | 19 February 2015 | Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease | Von Willebrand's Disease | Drug: von Willebrand factor | National Center for Research Resources (NCRR) | University of North Carolina | Not recruiting | N/A | N/A | Both | 10 | Phase 1 |