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ACTIVE NOT RECRUITING
NCT05181618
PHASE4

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

View on ClinicalTrials.gov

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

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.

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