Trial Condition(s):
Hemophilia A
BAY79-4980 compared to rFVIII-FS in previously treated patients with severe hemophilia A
Bayer Identifier:
12781
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.
Inclusion Criteria
- Males aged 12 to 70 years - Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C) - Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total - Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule - Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records - Subjects with no measurable inhibitor activity - Subjects with no history of FVIII inhibitor antibody formation - Written informed consent by subject and parent / legal representative, if < 18 years
Exclusion Criteria
- Subjects who are receiving primary prophylaxis - Subjects on prophylaxis with documented requirements of > 75 IU/kg/week - Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease) - Subjects with abnormal renal function - Subjects with elevated hepatic transaminases - Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study - Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG) - Subjects who require any pre-medication for FVIII injections
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Pollmann Münster, Germany, 48143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vivantes Klinikum im Friedrichshain Berlin, Germany, 10249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Birmingham, United Kingdom, B15 2TH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Thomas' Hospital London, United Kingdom, SE1 7EH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hallamshire Hospital Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hemophilia Treatment Center of Las Vegas Las Vegas, United States, 89109-2803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hemophilia Center of Western New York Buffalo, United States, 14215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, San Francisco San Francisco, United States, 94143-0324 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Wisconsin Milwaukee, United States, 53226 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cincinnati Children's Hospital Medical Center Cincinnati, United States, 45229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pennsylvania Philadelphia , United States, 19104-0506 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manchester Royal Infirmary Manchester, United Kingdom, M13 9WL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gulf States Hemophilia & Thrombophilia Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mountain States Regional Hemophilia & Thrombosis Center Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital Boston Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Orange County Orange , United States, 92868 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California - Davis Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Michigan State University East Lansing , United States, 48823 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hemophilia Center of Western Pennsylvania Pittsburgh, United States, 15213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cochin - Paris PARIS, France, 75674 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital J. Minjoz - Besançon BESANCON, France, 25030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU STRASBOURG - Hôpital de Hautepierre STRASBOURG, France, 67091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rochester General Hospital Rochester, United States, 14621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tulane University New Orleans, United States, 70112-2699 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brigham & Women's Hospital Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of New Mexico Albuquerque, United States, 87131-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Mercy Hospital Kansas City, United States, 64108-9898 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University Medical Center Winston-Salem, United States, 27157-1009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire - Le Kremlin Bicêtre LE KREMLIN-BICETRE, France, 94275 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint-Eloi - Montpellier Cedex MONTPELLIER CEDEX, France, 34059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Necker les enfants malades - Paris PARIS, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pontchaillou - Rennes CHU RENNES CEDEX, France, 35033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 31-501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia Poznan, Poland, 61-833 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Hematologii i Transfuzjologii Warszawa, Poland, 02-776 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fond. Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Giovanni Battista Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico - Vittorio Emanuele Catania, Italy, 95124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL NA/1 Napoli - Campania Napoli, Italy, 80144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central de Asturias Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alberta Edmonton, Canada, T6G 2C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Health Sciences Centre Halifax, Canada, B3H 2Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Michael's Hospital Health Centre Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojew. Szpital Specjalistyczny im. M. Kopernika Lodz, Poland, 93-510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Nuestra Señora de la Candelaria Sta. Cruz de Tenerife, Spain, 38009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Foothills Medical Centre Calgary, Canada, T2N 2T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations McMaster Children's Hospital Hamilton, Canada, L8S 4J9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital for Sick Children Toronto, Canada, M5G 1X8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HUDERF / UKZKF BRUXELLES - BRUSSEL, Belgium, 1020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Perth Hospital Perth, Australia, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ramos Mejía Buenos Aires, Argentina, C1221ADC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dr. Sotero del Río Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35-100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akdeniz Universitesi Tip Fakultesi Hastanesi Antalya, Turkey, 07059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seamen's hospital Klaipeda, Lithuania, 50809 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Hospital of North Estonia Tallin, Estonia, 13419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3508 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aarhus Universitetshospital, Skejby Århus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rikshospitalet Oslo, Norway, 0027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inst. de Investigaciones Hematológicas “Mariano R Castex" Buenos Aires, Argentina, C1425AUM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto de Hematología Dr. Rubén Dávoli Rosario, Argentina, S2000CKF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dr. Roberto del Río Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Luis Calvo Mackenna Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cukurova Universitesi Tip Fakultesi Hastanesi Adana, Turkey, 01-330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children´s hospital at Vilnius university Vilnius, Lithuania, 08661 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tallinn Children´s Hospital Tallinn, Estonia, 13419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haematology Service, Canterbury Health Laboratories Christchurch, New Zealand, 8001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Auckland City Hosptial Auckland, New Zealand, 1023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicki Bolnicki Centar Zagreb Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Emergency County Hospital Brasov Brasov, Romania, 50035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Emergency Hospital for Children "Louis Turcanu" Timisoara, Romania, 300011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundeni Clinical Institute Bucharest, Romania, 022328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, active-controlled, double-blind, parallel design study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY79-4980 compared to three times-per-week prophylaxis with rFVIII-FS in previously treated patients with severe hemophilia A
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Percentage of participants with less than 9 total bleeds per yearTimeframe: up to one year
Secondary Outcome
- Percentage of participants with less than 5 joint bleeds per yearTimeframe: up to one year
- Number of joint bleeds per participant per year in respondersTimeframe: up to one year
Additional Information
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