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:

NCT00623727

EudraCT Number:

2007-003718-32

Terminated/Withdrawn

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
143
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Kogenate FS Liposome (Recomb. F VIII, BAY79-4980)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Praxis Hr. Dr. H. Pollmann

Münster, Germany, 48143

Status
Terminated
 
Locations

Vivantes Klinikum im Friedrichshain

Berlin, Germany, 10249

Status
Completed
 
Locations

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Status
Completed
 
Locations

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Status
Completed
 
Locations

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Terminated
 
Locations

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Status
Terminated
 
Locations

Hemophilia Treatment Center of Las Vegas

Las Vegas, United States, 89109-2803

Status
Completed
 
Locations

Hemophilia Center of Western New York

Buffalo, United States, 14215

Status
Terminated
 
Locations

University of California, San Francisco

San Francisco, United States, 94143-0324

Status
Completed
 
Locations

Children's Hospital of Wisconsin

Milwaukee, United States, 53226

Status
Completed
 
Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, United States, 45229

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia , United States, 19104-0506

Status
Completed
 
Locations

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Status
Completed
 
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Terminated
 
Locations

Gulf States Hemophilia & Thrombophilia Center

Houston, United States, 77030

Status
Terminated
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Completed
 
Locations

Mountain States Regional Hemophilia & Thrombosis Center

Aurora, United States, 80045

Status
Completed
 
Locations

Children's Hospital Boston

Boston, United States, 02115

Status
Completed
 
Locations

Children's Hospital of Orange County

Orange , United States, 92868

Status
Completed
 
Locations

University of California - Davis

Sacramento, United States, 95817

Status
Completed
 
Locations

Michigan State University

East Lansing , United States, 48823

Status
Completed
 
Locations

Hemophilia Center of Western Pennsylvania

Pittsburgh, United States, 15213

Status
Terminated
 
Locations

Hôpital de la Timone - Marseille

MARSEILLE, France, 13005

Status
Completed
 
Locations

Cochin - Paris

PARIS, France, 75674

Status
Terminated
 
Locations

Hopital J. Minjoz - Besançon

BESANCON, France, 25030

Status
Terminated
 
Locations

CHU STRASBOURG - Hôpital de Hautepierre

STRASBOURG, France, 67091

Status
Terminated
 
Locations

Rochester General Hospital

Rochester, United States, 14621

Status
Terminated
 
Locations

Tulane University

New Orleans, United States, 70112-2699

Status
Terminated
 
Locations

Brigham & Women's Hospital

Boston, United States, 02115

Status
Completed
 
Locations

University of New Mexico

Albuquerque, United States, 87131-0001

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Terminated
 
Locations

Children's Mercy Hospital

Kansas City, United States, 64108-9898

Status
Completed
 
Locations

Wake Forest University Medical Center

Winston-Salem, United States, 27157-1009

Status
Terminated
 
Locations

Centre Hospitalier Universitaire - Le Kremlin Bicêtre

LE KREMLIN-BICETRE, France, 94275

Status
Terminated
 
Locations

Hôpital Saint-Eloi - Montpellier Cedex

MONTPELLIER CEDEX, France, 34059

Status
Completed
 
Locations

Hopital Necker les enfants malades - Paris

PARIS, France, 75015

Status
Terminated
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Terminated
 
Locations

Hôpital Pontchaillou - Rennes CHU

RENNES CEDEX, France, 35033

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31-501

Status
Completed
 
Locations

Wielospecjalistyczny Szpital Miejski im. Jozefa Strusia

Poznan, Poland, 61-833

Status
Completed
 
Locations

Instytut Hematologii i Transfuzjologii

Warszawa, Poland, 02-776

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Status
Completed
 
Locations

IRCCS Fond. Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

A.O.U. San Giovanni Battista

Torino, Italy, 10126

Status
Completed
 
Locations

A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95124

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

ASL NA/1 Napoli - Campania

Napoli, Italy, 80144

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Terminated
 
Locations

Hospital Central de Asturias

Oviedo, Spain, 33006

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Terminated
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

University of Alberta

Edmonton, Canada, T6G 2C8

Status
Completed
 
Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 2Y9

Status
Terminated
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

St. Michael's Hospital Health Centre

Toronto, Canada, M5B 1W8

Status
Completed
 
Locations

Wojew. Szpital Specjalistyczny im. M. Kopernika

Lodz, Poland, 93-510

Status
Completed
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Terminated
 
Locations

Hospital de Nuestra Señora de la Candelaria

Sta. Cruz de Tenerife, Spain, 38009

Status
Terminated
 
Locations

Foothills Medical Centre

Calgary, Canada, T2N 2T9

Status
Completed
 
Locations

McMaster Children's Hospital

Hamilton, Canada, L8S 4J9

Status
Terminated
 
Locations

Hospital for Sick Children

Toronto, Canada, M5G 1X8

Status
Terminated
 
Locations

HUDERF / UKZKF

BRUXELLES - BRUSSEL, Belgium, 1020

Status
Terminated
 
Locations

Royal Perth Hospital

Perth, Australia, 6000

Status
Terminated
 
Locations

Hospital Ramos Mejía

Buenos Aires, Argentina, C1221ADC

Status
Terminated
 
Locations

Hospital Dr. Sotero del Río

Santiago de Chile, Chile

Status
Terminated
 
Locations

Ege Universitesi Tip Fakultesi

Izmir, Turkey, 35-100

Status
Completed
 
Locations

Akdeniz Universitesi Tip Fakultesi Hastanesi

Antalya, Turkey, 07059

Status
Completed
 
Locations

Seamen's hospital

Klaipeda, Lithuania, 50809

Status
Terminated
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 10002

Status
Terminated
 
Locations

Regional Hospital of North Estonia

Tallin, Estonia, 13419

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Terminated
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Universitair Medisch Centrum Groningen

GRONINGEN, Netherlands, 9713 GZ

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

University Medical Center Utrecht

UTRECHT, Netherlands, 3508 GA

Status
Terminated
 
Locations

Aarhus Universitetshospital, Skejby

Århus N, Denmark, 8200

Status
Completed
 
Locations

Rikshospitalet

Oslo, Norway, 0027

Status
Completed
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2132

Status
Terminated
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Inst. de Investigaciones Hematológicas “Mariano R Castex"

Buenos Aires, Argentina, C1425AUM

Status
Terminated
 
Locations

Instituto de Hematología Dr. Rubén Dávoli

Rosario, Argentina, S2000CKF

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Terminated
 
Locations

Hospital Dr. Roberto del Río

Santiago, Chile

Status
Terminated
 
Locations

Hospital Luis Calvo Mackenna

Santiago, Chile

Status
Terminated
 
Locations

Cukurova Universitesi Tip Fakultesi Hastanesi

Adana, Turkey, 01-330

Status
Completed
 
Locations

Children´s hospital at Vilnius university

Vilnius, Lithuania, 08661

Status
Terminated
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Terminated
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 500

Status
Terminated
 
Locations

Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Terminated
 
Locations

Tallinn Children´s Hospital

Tallinn, Estonia, 13419

Status
Terminated
 
Locations

Haematology Service, Canterbury Health Laboratories

Christchurch, New Zealand, 8001

Status
Terminated
 
Locations

Auckland City Hosptial

Auckland, New Zealand, 1023

Status
Terminated
 
Locations

Klinicki Bolnicki Centar Zagreb

Zagreb, Croatia, 10000

Status
Completed
 
Locations

Clinical Emergency County Hospital Brasov

Brasov, Romania, 50035

Status
Terminated
 
Locations

Clinical Emergency Hospital for Children "Louis Turcanu"

Timisoara, Romania, 300011

Status
Terminated
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022328

Status
Terminated
 

Trial Design