A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

February 10, 2020

Primary Completion Date

October 30, 2021

Study Completion Date

December 31, 2025

Conditions
Mild Hereditary Factor VIII Deficiency Disease Without InhibitorModerate Hereditary Factor VIII Deficiency Disease Without InhibitorHemophilia A
Interventions
DRUG

Emicizumab

Four loading doses of emicizumab 3 milligrams per kilogram of body weight (mg/kg) will be administered subcutaneously (SC) once a week (QW) for 4 weeks followed by participant's preference of one of the three following maintenance SC dose regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W).

Trial Locations (22)

1200

Cliniques Universitaires St-Luc, Brussels

2193

Charlotte Maxeke Johannesburg Hospital, Johannesburg

3000

UZ Leuven Gasthuisberg, Leuven

28046

Hospital Universitario la Paz, Madrid

30308

Hemophilia of Georgia Center for Bleeding & Clotting Disorders, Atlanta

41013

Hospital Universitario Virgen del Rocio, Seville

46260

Indiana Hemophilia & Thrombosis center, Indianapolis

48109

University of Michigan, C.S. Mott Children's Hospital, Ann Arbor

53127

Universitätsklinikum Bonn, Bonn

69677

Hopital Cardio-vasculaire Louis Pradel, Bron

75015

Groupe Hospitalier Necker Enfants Malades, Paris

80336

Klinikum der Universität München, Campus Innenstadt, München

90027

Childrens Hospital LA, Los Angeles

94275

CH de Bicetre, Le Kremlin-Bicêtre

98101

Washington Institute for Coagulation, Seattle

T6G 1Z1

Kaye Edmonton Clinic, Edmonton

A1B 3V6

Eastern Health - General Hospital, St. John's

1105 AZ

Amsterdam UMC Location AMC, Amsterdam

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

CF14 4XW

Cardiff and Vale NHS Trust, Cardiff

NW3 2QG

Royal Free Hospital, London

WC1N 3HR

Great Ormond street Hospital for Children NHS Foundation Trust, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04158648 - A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors | Biotech Hunter | Biotech Hunter