NCT05662319 - A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

May 15, 2027

Study Completion Date

June 1, 2028

Conditions

Hemophilia

Interventions

DRUG

Fitusiran

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous (SC)

DRUG

Clotting factor concentrates (CFC) or bypassing agents (BPA)

"* Coagulation factor VIII (ATC code: B02BD02)~* Coagulation factor IX (ATC code: B02BD04)~* Coagulation factor VIIa (ATC code: B02BD08)~* Factor VIII inhibitor bypassing activity (ATC code: B02BD03)~Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)"

DRUG

Antithrombin concentrate (ATIIIC)

Antithrombin III (ATC code: B01AB02) Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)

Trial Locations (50)

100

Investigational Site Number : 1580001, Taipei

1501

Investigational Site Number : 7100003, Johannesburg

2193

Investigational Site Number : 7100001, Parktown

10249

Investigational Site Number : 2760001, Berlin

11031

Investigational Site Number : 1580003, Taipei

11040

Northwell Health Hemostasis and Thrombosis Center Site Number : 8400015, New Hyde Park

11527

Investigational Site Number : 3000002, Athens

15006

Investigational Site Number : 7240002, A Coruña

20089

Investigational Site Number : 3800003, Rozzano

20122

Investigational Site Number : 3800001, Milan

20246

Investigational Site Number : 2760002, Hamburg

21423

Investigational Site Number : 6820002, Jeddah

31000

Investigational Site Number : 4840004, Chihuahua City

34390

Investigational Site Number : 7920001, Çapa

44106

University Hospitals of Cleveland Site Number : 8400001, Cleveland

50009

Investigational Site Number : 7240003, Zaragoza

55454

M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400016, Minneapolis

59037

Investigational Site Number : 2500002, Lille

64460

Investigational Site Number : 4840002, Monterrey

75015

Investigational Site Number : 2500001, Paris

75235

Children's Medical Center Dallas- Site Number : 8400018, Dallas

77030

Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400002, Houston

91900

Investigational Site Number : 4840001, Veracruz

94275

Investigational Site Number : 2500003, Le Kremlin-Bicêtre

100045

Investigational Site Number : 1560003, Beijing

141008

Investigational Site Number : 3560006, Punjab

250013

Investigational Site Number : 1560002, Jinan

510515

Investigational Site Number : 1560001, Guangzhou

632004

Investigational Site Number : 3560003, Vellore

751019

Investigational Site Number : 3560007, Bhubaneswar

4668560

Investigational Site Number : 3920003, Nagoya

92868-4306

Center for Inherited Blood Disorders (CIBD) Site Number : 8400012, Orange

07601

Hackensack University Site Number : 8400009, Hackensack

15224-1334

UPMC Children's Hospital of Pittsburgh-4401 Penn Ave Site Number : 8400017, Pittsburgh

L8N 3Z5

Investigational Site Number : 1240001, Hamilton

Investigational Site Number : 1240002, Hamilton

M5G 1X8

Investigational Site Number : 1240004, Toronto

115 27

Investigational Site Number : 3000001, Athens

560 034

Investigational Site Number : 3560004, Bangalore

411 011

Investigational Site Number : 3560001, Pune-411011

634-8522

Investigational Site Number : 3920001, Kashihara-shi

330-8777

Investigational Site Number : 3920002, Saitama-shi

30-688

Investigational Site Number : 6160002, Krakow

93-510

Investigational Site Number : 6160004, Lodz

02-776

Investigational Site Number : 6160001, Warsaw

03722

Investigational Site Number : 4100001, Seoul

05278

Investigational Site Number : 4100002, Seoul

01130

Investigational Site Number : 7920002, Adana

07059

Investigational Site Number : 7920004, Akdeniz

TR-35100

Investigational Site Number : 7920003, Izmir