Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
NCT ID: NCT01454739
Last Updated: 2020-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2011-12-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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On-Demand
The individual dose of rFVIIIFc to treat bleeding episodes will be based on participant's clinical condition, type and severity of the bleeding event, and if indicated, Factor VIII (FVIII) levels.
rFVIIIFc
Administered as specified in the treatment arm.
Prophylaxis
Tailored prophylaxis, Weekly prophylaxis or Personalized prophylaxis available.
rFVIIIFc
Administered as specified in the treatment arm.
Interventions
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rFVIIIFc
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable).
Exclusion Criteria
0 Years
MALE
No
Sponsors
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Bioverativ Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Bioverativ Therapeutics Inc.
Locations
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Research Site
Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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East Lansing, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Camperdown, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Subiaco, Western Australia, Australia
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Vienna, , Austria
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Brussels, Brussels Capital, Belgium
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Campinas, São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Bron, Rhone, France
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Bonn, North Rhine-Westphalia, Germany
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Berlin, , Germany
Children Cancer Centre
Hong Kong, New Territories, Hong Kong
Sir Yue Kong Pao Center for Cancer
Hong Kong, New Territories, Hong Kong
Research Site
Hong Kong, , Hong Kong
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Bangalore, Karnataka, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Ludhiana, Punjab, India
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Vellore, Tamil Nadu, India
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Dublin, , Ireland
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Ramat Gan, , Israel
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Florence, , Italy
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Milan, , Italy
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Vicenza, , Italy
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Nagoya, Aichi-ken, Japan
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Kitakyushu, Fukuoka, Japan
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Kawasaki, Kanagawa, Japan
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Kashihara-shi, Nara, Japan
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Shinjuku-ku, Tokyo-To, Japan
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Tokyo, Tokyo-To, Japan
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Groningen, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Palmerston North, , New Zealand
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Wellington, , New Zealand
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Lublin, , Poland
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Johannesburg, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Barcelona, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Zurich, , Switzerland
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Cambridge, Cambridgeshire, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Basingstoke, Hampshire, United Kingdom
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Hamstead, London, United Kingdom
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Glasgow, Strathclyde, United Kingdom
Research Site
Glasgow, Strathclyde, United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Raheja P, Kragh N, Bystricka L, Eriksson D, Aroui K, Mezghani M, Barbier S, Linari S. Long-term efmoroctocog alfa prophylaxis improves perceived pain, mental, and physical health in patients with hemophilia A: post hoc analysis of phase III trials using patient-reported outcomes. Ther Adv Hematol. 2024 Jul 30;15:20406207241257917. doi: 10.1177/20406207241257917. eCollection 2024.
Nolan B, Mahlangu J, Pabinger I, Young G, Konkle BA, Barnes C, Nogami K, Santagostino E, Pasi KJ, Khoo L, Winding B, Yuan H, Fruebis J, Rudin D, Oldenburg J. Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study. Haemophilia. 2020 May;26(3):494-502. doi: 10.1111/hae.13953. Epub 2020 Mar 30.
Nolan B, Mahlangu J, Perry D, Young G, Liesner R, Konkle B, Rangarajan S, Brown S, Hanabusa H, Pasi KJ, Pabinger I, Jackson S, Cristiano LM, Li X, Pierce GF, Allen G. Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A. Haemophilia. 2016 Jan;22(1):72-80. doi: 10.1111/hae.12766. Epub 2015 Jul 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-003072-37
Identifier Type: -
Identifier Source: secondary_id
8HA01EXT
Identifier Type: -
Identifier Source: org_study_id