Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
NCT ID: NCT01736475
Last Updated: 2021-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
159 participants
INTERVENTIONAL
2013-01-31
2014-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prophylaxis
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
Pharmacokinetic (PK) evaluation of ADVATE
PEGylated Recombinant Factor VIII
Pharmacokinetic (PK) evaluation of BAX 855
PEGylated Recombinant Factor VIII
Prophylaxis treatment
On-demand
PEGylated Recombinant Factor VIII
On-demand treatment
Interventions
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Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
Pharmacokinetic (PK) evaluation of ADVATE
PEGylated Recombinant Factor VIII
Pharmacokinetic (PK) evaluation of BAX 855
PEGylated Recombinant Factor VIII
Prophylaxis treatment
PEGylated Recombinant Factor VIII
On-demand treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is 12 to 65 years old at the time of screening
* Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity \< 1%) as confirmed by central laboratory at screening after the appropriate washout period or a documented FVIII clotting activity \<1%
* Participant has been previously treated with plasma-derived FVIII concentrates or recombinant FVIII for ≥150 documented exposure days (EDs)
* Participant is currently receiving prophylaxis or on-demand therapy with FVIII
* Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria
* Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time prior to screening
* Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
12 Years
65 Years
MALE
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Colorado
Aurora, Colorado, United States
University of Florida, College of Medicine
Gainesville, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Tulane University Medical School
New Orleans, Louisiana, United States
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Palmetto Health
Columbia, South Carolina, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Puget Sound Blood Group
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Clayton, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Hollywood Specialist Centre
Nedlands, Western Australia, Australia
Landes-Frauen-und Kinderklinik Linz
Linz, , Austria
AKH - Medizinische Universität Wien
Vienna, , Austria
SHAT of Oncohaematology Diseases
Sofia, , Bulgaria
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Gerinnungszentrum Rhein-Ruhr
Duisburg, North Rhine-Westphalia, Germany
Vivantes Klinikum im Friedrichshain - Landsberger Allee
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Werlhof-Institut MVZ
Hanover, , Germany
Rambam Health Care Campus
Haifa, , Israel
Chaim Sheba Medical Center
Tel Aviv, , Israel
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyōgo, Japan
St. Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo-To, Japan
Ogikubo Hospital
Suginami-ku, Tokyo-To, Japan
Vilnius University Hospital Santariskiu Clinics, Public Institution
Vilnius, , Lithuania
Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Tengku Ampuan Rahimah
Klang, Selangor, Malaysia
Pusat Darah Negara
Kuala Lumpur, , Malaysia
Academisch Medisch Centrum
Amsterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Wojewodzki Szpital Specjalistyczny im.M.Kopernika w Lodzi
Lodz, , Poland
Sanador SRL
Bucharest, , Romania
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Eulji University Hospital
Daejeon, , South Korea
Kyung hee University Hospital at Gangdong
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Regional Universitario de Malaga
Málaga, Málaga, Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Skånes Universitetssjukhus, Malmö
Malmo, , Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Universitatsspital Zurich
Zurich, , Switzerland
Tri-Service General Hospital
Taipei, , Taiwan
SI V.K.Gusak Emergency and Reconstructive Surgery Institute of NAMSU Center of IT
Donetsk, , Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
Lviv, , Ukraine
Bristol Royal Hospital for Children
Bristol, Avon, United Kingdom
Royal Free Hospital
London, Greater London, United Kingdom
St Thomas' Hospital
London, Greater London, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom
Royal Manchester Children's Hospital
Manchester, Greater Manchester, United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Countries
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References
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Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8.
Other Identifiers
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2012-003599-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
261201
Identifier Type: -
Identifier Source: org_study_id
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