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ACTIVE NOT RECRUITING
NCT03754790
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

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