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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

281

Participants

Timeline

Start Date

January 9, 2019

Primary Completion Date

November 5, 2026

Study Completion Date

November 5, 2026

Conditions
Hemophilia
Interventions
DRUG

Fitusiran

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Trial Locations (79)

8

Investigational Site Number : 3720002, Dublin

12

Investigational Site Number : 3720001, Crumlin

100

Investigational Site Number : 1580003, Taipei

110

Investigational Site Number : 1580001, Taipei

112

Investigational Site Number : 1580005, Taipei

500

Investigational Site Number : 1580002, Changhua

1134

Investigational Site Number : 3480002, Budapest

1135

Investigational Site Number : 8040003, Kyiv

2050

Investigational Site Number : 0360001, Camperdown

2100

Investigational Site Number : 2080001, Copenhagen

3181

Investigational Site Number : 0360003, Prahran

3722

Investigational Site Number : 4100004, Seoul

6001

Investigational Site Number : 7100002, Port Elizabeth

6961

Investigational Site Number : 0360002, Murdoch

10249

Investigational Site Number : 2760001, Berlin

20122

Investigational Site Number : 3800002, Milan

27100

Investigational Site Number : 7920006, Gaziantep

32207

Nemours Children's Clinic Site Number : 8400008, Jacksonville

33305

Investigational Site Number : 1580007, Taoyuan

33607

St Joseph's Children's Hospital of Tampa Site Number : 8400002, Tampa

34093

Investigational Site Number : 7920005, Istanbul

35100

Investigational Site Number : 7920012, Bornova

35128

Investigational Site Number : 3800004, Padua

35233

Investigational Site Number : 4100002, Daejeon

38039

Investigational Site Number : 7920008, Kayseri

40201

Investigational Site Number : 1580008, Taichung

40705

Investigational Site Number : 1580004, Taichung

44308

Childrens Hospital Medical Center of Akron Site Number : 8400006, Akron

54058

Investigational Site Number : 8040004, Mykolaiv

55200

Investigational Site Number : 7920007, Samsun

68000

Investigational Site Number : 4580003, Ampang

69677

Investigational Site Number : 2500002, Lyon

75015

Investigational Site Number : 2500003, Paris

79044

Investigational Site Number : 8040002, Lviv

80100

Investigational Site Number : 4580001, Johor Bahru

85016

Phoenix Childrens Hospital Site Number : 8400009, Phoenix

88586

Investigational Site Number : 4580002, Kota Kinabalu

89147

Investigational Site Number : 1560005, Hangzhou

90027

Children's Hospital Los Angeles Site Number : 8400019, Los Angeles

92868

Center for Inherited Blood Disorders (CIBD) Site Number : 8400016, Orange

100045

Investigational Site Number : 1560004, Beijing

100730

Investigational Site Number : 1560007, Beijing

200025

Investigational Site Number : 1560003, Shanghai

215006

Investigational Site Number : 1560006, Suzhou

226003

Investigational Site Number : 3560005, Lucknow

250013

Investigational Site Number : 1560008, Jinan

266555

Investigational Site Number : 1560010, Qingdao

410008

Investigational Site Number : 1560014, Changsha

411001

Investigational Site Number : 3560002, Pune

411004

Investigational Site Number : 3560010, Pune

510515

Investigational Site Number : 1560002, Guangzhou

550004

Investigational Site Number : 1560011, Guiyang

560034

Investigational Site Number : 3560001, Bangalore

610091

Investigational Site Number : 1560009, Chengdu

632517

Investigational Site Number : 3560004, Ranipet

650000

Investigational Site Number : 1560012, Kunming

730000

Investigational Site Number : 1560013, Lanzhou

1600023

Investigational Site Number : 3920008, Tokyo

2591193

Investigational Site Number : 3920005, Isehara

4668560

Investigational Site Number : 3920001, Nagoya

5262100

Investigational Site Number : 3760001, Ramat Gan

8078555

Investigational Site Number : 3920003, Kitakyushu

60612-3863

Rush University Medical Center -1725 W Harrison St Site Number : 8400001, Chicago

02114

~Massachusetts General Hospital Site Number : 8400011, Boston

48109-5000

University of Michigan Hospital - 1500 E Medical Center Dr Site Number : 8400012, Ann Arbor

89135-3011

Alliance for Childhood Diseases Site Number : 8400007, Las Vegas

H1T 2M4

Investigational Site Number : 1240001, Montreal

04103

Investigational Site Number : 2760003, Leipzig

400 022

Investigational Site Number : 3560007, Mumbai

663-8501

Investigational Site Number : 3920002, Nishinomiya

330-8777

Investigational Site Number : 3920004, Saitama

602-739

Investigational Site Number : 4100001, Busan

03722

Investigational Site Number : 4100003, Seoul

01130

Investigational Site Number : 7920002, Adana

07059

Investigational Site Number : 7920004, Akdeniz

TR-35100

Investigational Site Number : 7920003, Izmir

04060

Investigational Site Number : 8040001, Kyiv

SE1 9RT

Investigational Site Number : 8260001, London

G4 0SF

Investigational Site Number : 8260004, Glasgow

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY