stop_circleTerminated/Withdrawn

Hemophilia A

Bayer Identifier:

12781

ClinicalTrials.gov Identifier:

NCT00623727

EudraCT Number:

2007-003718-32

EU CT Number:

Not Available
BAY79-4980 compared to rFVIII-FS in previously treated patients with severe hemophilia A

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.

Key Participants Requirements

Sex

Male

Age

12 - 70 Years
  • - 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
  • - 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
143
Trial Dates
June 2008 - October 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Kogenate FS Liposome (Recomb. F VIII, BAY79-4980)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Terminated
Praxis Hr. Dr. H. PollmannMünster, 48143, Germany
Completed
Vivantes Klinikum im FriedrichshainBerlin, 10249, Germany
Completed
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Completed
St Thomas' HospitalLondon, SE1 7EH, United Kingdom
Terminated
Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Terminated
University Hospital of WalesCardiff, CF14 4XW, United Kingdom
Completed
Hemophilia Treatment Center of Las VegasLas Vegas, 89109-2803, United States
Terminated
Hemophilia Center of Western New YorkBuffalo, 14215, United States
Completed
University of California, San FranciscoSan Francisco, 94143-0324, United States
Completed
Children's Hospital of WisconsinMilwaukee, 53226, United States
Completed
Cincinnati Children's Hospital Medical CenterCincinnati, 45229, United States
Completed
University of PennsylvaniaPhiladelphia, 19104-0506, United States
Completed
Manchester Royal InfirmaryManchester, M13 9WL, United Kingdom
Terminated
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Terminated
Gulf States Hemophilia & Thrombophilia CenterHouston, 77030, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Mountain States Regional Hemophilia & Thrombosis CenterAurora, 80045, United States
Completed
Children's Hospital BostonBoston, 02115, United States
Completed
Children's Hospital of Orange CountyOrange, 92868, United States
Completed
University of California - DavisSacramento, 95817, United States
Completed
Michigan State UniversityEast Lansing, 48823, United States
Terminated
Hemophilia Center of Western PennsylvaniaPittsburgh, 15213, United States
Completed
Hôpital de la Timone - MarseilleMARSEILLE, 13005, France
Terminated
Cochin - ParisPARIS, 75674, France
Terminated
Hopital J. Minjoz - BesançonBESANCON, 25030, France
Terminated
CHU STRASBOURG - Hôpital de HautepierreSTRASBOURG, 67091, France
Terminated
Rochester General HospitalRochester, 14621, United States
Terminated
Tulane UniversityNew Orleans, 70112-2699, United States
Completed
Brigham & Women's HospitalBoston, 02115, United States
Completed
University of New MexicoAlbuquerque, 87131-0001, United States
Terminated
Mayo Clinic - RochesterRochester, 55905, United States
Completed
Children's Mercy HospitalKansas City, 64108-9898, United States
Terminated
Wake Forest University Medical CenterWinston-Salem, 27157-1009, United States
Terminated
Centre Hospitalier Universitaire - Le Kremlin BicêtreLE KREMLIN-BICETRE, 94275, France
Completed
Hôpital Saint-Eloi - Montpellier CedexMONTPELLIER CEDEX, 34059, France
Terminated
Hopital Necker les enfants malades - ParisPARIS, 75015, France
Terminated
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69437, France
Completed
Hôpital Pontchaillou - Rennes CHURENNES CEDEX, 35033, France
Completed
Szpital Uniwersytecki w KrakowieKrakow, 31-501, Poland
Completed
Wielospecjalistyczny Szpital Miejski im. Jozefa StrusiaPoznan, 61-833, Poland
Completed
Instytut Hematologii i TransfuzjologiiWarszawa, 02-776, Poland
Completed
Uniwersyteckie Centrum KliniczneGdansk, 80-952, Poland
Completed
IRCCS Fond. Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. San Giovanni BattistaTorino, 10126, Italy
Completed
A.O.U. Policlinico - Vittorio EmanueleCatania, 95124, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
ASL NA/1 Napoli - CampaniaNapoli, 80144, Italy
Terminated
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital Central de AsturiasOviedo, 33006, Spain
Terminated
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
University of AlbertaEdmonton, T6G 2C8, Canada
Terminated
Queen Elizabeth II Health Sciences CentreHalifax, B3H 2Y9, Canada
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
St. Michael's Hospital Health CentreToronto, M5B 1W8, Canada
Completed
Wojew. Szpital Specjalistyczny im. M. KopernikaLodz, 93-510, Poland
Completed
A.O.U. Federico IINapoli, 80131, Italy
Terminated
Hospital Universitario "La Paz"Madrid, 28046, Spain
Terminated
Hospital de Nuestra Señora de la CandelariaSta. Cruz de Tenerife, 38009, Spain
Completed
Foothills Medical CentreCalgary, T2N 2T9, Canada
Terminated
McMaster Children's HospitalHamilton, L8S 4J9, Canada
Terminated
Hospital for Sick ChildrenToronto, M5G 1X8, Canada
Terminated
HUDERF / UKZKFBRUXELLES - BRUSSEL, 1020, Belgium
Terminated
Royal Perth HospitalPerth, 6000, Australia
Terminated
Hospital Ramos MejíaBuenos Aires, C1221ADC, Argentina
Terminated
Hospital Dr. Sotero del RíoSantiago de Chile, Chile
Completed
Ege Universitesi Tip FakultesiIzmir, 35-100, Turkey
Completed
Akdeniz Universitesi Tip Fakultesi HastanesiAntalya, 07059, Turkey
Terminated
Seamen's hospitalKlaipeda, 50809, Lithuania
Terminated
National Taiwan University HospitalTaipei, 10002, Taiwan
Terminated
Regional Hospital of North EstoniaTallin, 13419, Estonia
Terminated
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Universitair Medisch Centrum GroningenGRONINGEN, 9713 GZ, Netherlands
Completed
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Terminated
University Medical Center UtrechtUTRECHT, 3508 GA, Netherlands
Completed
Aarhus Universitetshospital, SkejbyÅrhus N, 8200, Denmark
Completed
RikshospitaletOslo, 0027, Norway
Terminated
University of WitwatersrandJohannesburg, 2132, South Africa
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Terminated
Inst. de Investigaciones Hematológicas “Mariano R Castex"Buenos Aires, C1425AUM, Argentina
Terminated
Instituto de Hematología Dr. Rubén DávoliRosario, S2000CKF, Argentina
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Terminated
Medizinische Universität GrazGraz, 8036, Austria
Terminated
Hospital Dr. Roberto del RíoSantiago, Chile
Terminated
Hospital Luis Calvo MackennaSantiago, Chile
Completed
Cukurova Universitesi Tip Fakultesi HastanesiAdana, 01-330, Turkey
Terminated
Children´s hospital at Vilnius universityVilnius, 08661, Lithuania
Terminated
Inselspital BernBern, 3010, Switzerland
Terminated
Changhua Christian HospitalChanghua, 500, Taiwan
Terminated
Veterans General HospitalTaipei, 11217, Taiwan
Terminated
Tallinn Children´s HospitalTallinn, 13419, Estonia
Terminated
Haematology Service, Canterbury Health LaboratoriesChristchurch, 8001, New Zealand
Terminated
Auckland City HosptialAuckland, 1023, New Zealand
Completed
Klinicki Bolnicki Centar ZagrebZagreb, 10000, Croatia
Terminated
Clinical Emergency County Hospital BrasovBrasov, 50035, Romania
Terminated
Clinical Emergency Hospital for Children "Louis Turcanu"Timisoara, 300011, Romania
Terminated
Fundeni Clinical InstituteBucharest, 022328, Romania

Primary Outcome

  • Percentage of participants with less than 9 total bleeds per year
    date_rangeTime Frame:
    up to one year
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants with less than 5 joint bleeds per year
    date_rangeTime Frame:
    up to one year
    enhanced_encryption
    Safety Issue:
    No
  • Number of joint bleeds per participant per year in responders
    date_rangeTime Frame:
    up to one year
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.