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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
Sponsor: Hoffmann-La Roche
Summary
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and \<70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study.
Official title: A Multicenter, Open-Label Phase IV Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes, in Participants Aged ≥13 and <70 Years With Severe or Moderate Hemophilia A Without FVIII Inhibitors on Emicizumab Prophylaxis
Key Details
Gender
All
Age Range
13 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2022-06-20
Completion Date
2027-05-21
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (28)
Orthopaedic Institute for Children
Los Angeles, California, United States
University of Miami Medical Center
Miami, Florida, United States
Oklahoma Children's Hospital ? Jimmy Everest Center
Oklahoma City, Oklahoma, United States
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Charité Universitätsklinikum Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, Hungary
AOU Federico II
Naples, Campania, Italy
Policlinico Univ. A. Gemelli
Rome, Lazio, Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
AOU Careggi
Florence, Tuscany, Italy
Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique
Rabat, Morocco
University Clinical Centre of Serbia
Belgrade, Serbia
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Vall de Hebron
Barcelona, Spain
Hospital Universitario la Paz
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
CHU Farhat Hached
Sousse, Tunisia
Aziza Othmana Hospital
Tunis, Tunisia
Gazi Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Akdeniz Uni School of Medicine
Antalya, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Ege Uni Medical School
Izmir, Turkey (Türkiye)
St Thomas Westminster
London, United Kingdom
Manchester University NHS Foundation Trust (MFT)
Manchester, United Kingdom