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Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX
Sponsor: Genzyme, a Sanofi Company
Summary
Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: * To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: * Bleeding episodes * Spontaneous bleeding episodes * Joint bleeding episodes * To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age
Official title: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX
Key Details
Gender
MALE
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
281
Start Date
2019-01-09
Completion Date
2026-11-05
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Fitusiran
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Locations (79)
Phoenix Childrens Hospital Site Number : 8400009
Phoenix, Arizona, United States
Children's Hospital Los Angeles Site Number : 8400019
Los Angeles, California, United States
Center for Inherited Blood Disorders (CIBD) Site Number : 8400016
Orange, California, United States
Nemours Children's Clinic Site Number : 8400008
Jacksonville, Florida, United States
St Joseph's Children's Hospital of Tampa Site Number : 8400002
Tampa, Florida, United States
Rush University Medical Center -1725 W Harrison St Site Number : 8400001
Chicago, Illinois, United States
~Massachusetts General Hospital Site Number : 8400011
Boston, Massachusetts, United States
University of Michigan Hospital - 1500 E Medical Center Dr Site Number : 8400012
Ann Arbor, Michigan, United States
Alliance for Childhood Diseases Site Number : 8400007
Las Vegas, Nevada, United States
Childrens Hospital Medical Center of Akron Site Number : 8400006
Akron, Ohio, United States
Investigational Site Number : 0360001
Camperdown, New South Wales, Australia
Investigational Site Number : 0360003
Prahran, Victoria, Australia
Investigational Site Number : 0360002
Murdoch, Western Australia, Australia
Investigational Site Number : 1240001
Montreal, Quebec, Canada
Investigational Site Number : 1560004
Beijing, China
Investigational Site Number : 1560007
Beijing, China
Investigational Site Number : 1560014
Changsha, China
Investigational Site Number : 1560009
Chengdu, China
Investigational Site Number : 1560002
Guangzhou, China
Investigational Site Number : 1560011
Guiyang, China
Investigational Site Number : 1560005
Hangzhou, China
Investigational Site Number : 1560008
Jinan, China
Investigational Site Number : 1560012
Kunming, China
Investigational Site Number : 1560013
Lanzhou, China
Investigational Site Number : 1560010
Qingdao, China
Investigational Site Number : 1560003
Shanghai, China
Investigational Site Number : 1560006
Suzhou, China
Investigational Site Number : 2080001
Copenhagen, Denmark
Investigational Site Number : 2500002
Lyon, France
Investigational Site Number : 2500003
Paris, France
Investigational Site Number : 2760001
Berlin, Germany
Investigational Site Number : 2760003
Leipzig, Germany
Investigational Site Number : 3480002
Budapest, Hungary
Investigational Site Number : 3560001
Bangalore, India
Investigational Site Number : 3560005
Lucknow, India
Investigational Site Number : 3560007
Mumbai, India
Investigational Site Number : 3560002
Pune, India
Investigational Site Number : 3560010
Pune, India
Investigational Site Number : 3560004
Ranipet, India
Investigational Site Number : 3720001
Crumlin, Dublin, Ireland
Investigational Site Number : 3720002
Dublin, Ireland
Investigational Site Number : 3760001
Ramat Gan, Israel
Investigational Site Number : 3800002
Milan, Lombardy, Italy
Investigational Site Number : 3800004
Padua, Veneto, Italy
Investigational Site Number : 3920002
Nishinomiya, Hyōgo, Japan
Investigational Site Number : 3920005
Isehara, Kanagawa, Japan
Investigational Site Number : 3920003
Kitakyushu, Japan
Investigational Site Number : 3920001
Nagoya, Japan
Investigational Site Number : 3920004
Saitama, Japan
Investigational Site Number : 3920008
Tokyo, Japan
Investigational Site Number : 4580003
Ampang, Malaysia
Investigational Site Number : 4580001
Johor Bahru, Malaysia
Investigational Site Number : 4580002
Kota Kinabalu, Malaysia
Investigational Site Number : 7100002
Port Elizabeth, South Africa
Investigational Site Number : 4100001
Busan, Busan, South Korea
Investigational Site Number : 4100002
Daejeon, Daejeon, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, South Korea
Investigational Site Number : 1580002
Changhua, Taiwan
Investigational Site Number : 1580008
Taichung, Taiwan
Investigational Site Number : 1580004
Taichung, Taiwan
Investigational Site Number : 1580003
Taipei, Taiwan
Investigational Site Number : 1580001
Taipei, Taiwan
Investigational Site Number : 1580005
Taipei, Taiwan
Investigational Site Number : 1580007
Taoyuan, Taiwan
Investigational Site Number : 7920002
Adana, Turkey (Türkiye)
Investigational Site Number : 7920004
Akdeniz, Turkey (Türkiye)
Investigational Site Number : 7920012
Bornova, Turkey (Türkiye)
Investigational Site Number : 7920006
Gaziantep, Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920008
Kayseri, Turkey (Türkiye)
Investigational Site Number : 7920007
Samsun, Turkey (Türkiye)
Investigational Site Number : 8040001
Kyiv, Ukraine
Investigational Site Number : 8040003
Kyiv, Ukraine
Investigational Site Number : 8040002
Lviv, Ukraine
Investigational Site Number : 8040004
Mykolaiv, Ukraine
Investigational Site Number : 8260001
London, London, City of, United Kingdom
Investigational Site Number : 8260004
Glasgow, United Kingdom