A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

June 20, 2022

Primary Completion Date

December 4, 2026

Study Completion Date

May 21, 2027

Conditions
Severe Hemophilia AModerate Hemophilia A
Interventions
DRUG

Emicizumab

The emicizumab dosing regimen will be 3 milligrams per kilogram of body weight (mg/kg) subcutaneously (SC) once a week (QW) for 4 weeks followed by participant preference of one of the following maintenance regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W) in agreement with the investigator.

Trial Locations (27)

1134

Észak-Pesti Centrumkórház - Honvédkórház, Budapest

4000

CHU Farhat Hached, Sousse

10090

Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique, Rabat

11000

University Clinical Centre of Serbia, Belgrade

13353

Charité Universitätsklinikum Berlin, Berlin

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

28046

Hospital Universitario la Paz, Madrid

29010

Hospital Regional Universitario Carlos Haya, Málaga

33136

University of Miami Medical Center, Miami

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

35100

Ege Uni Medical School, Izmir

50134

AOU Careggi, Florence

53127

Universitätsklinikum Bonn, Bonn

73104

Oklahoma Children's Hospital ? Jimmy Everest Center, Oklahoma City

80131

AOU Federico II, Napoli

90007

Orthopaedic Institute for Children, Los Angeles

13083-878

Hospital das Clinicas - UNICAMP, Campinas

14051-140

Hospital das Clínicas Faculdades Médicas de Ribeirão Preto, Ribeirão Preto

L9H 2B7

Hamilton Health Sciences Corporation, Hamilton

00168

Policlinico Univ. A. Gemelli, Rome

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitario Vall de Hebron, Barcelona

Unknown

Aziza Othmana Hospital, Tunis

06500

Gazi Universitesi Tip Fakultesi, Ankara

07059

Akdeniz Uni School of Medicine, Antalya

SE1 7EH

St Thomas Westminster, London

M13 9WL

Manchester University NHS Foundation Trust (MFT), Manchester

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY