RecruitingPhase 3NCT07416604

A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A


Sponsor

Hoffmann-La Roche

Enrollment

360 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Emicizumab and NXT007 for people with hemophilia a. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTNXT007

NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.

DRUGEmicizumab

Emicizumab will be administered subcutaneously (SC) using vial and syringe.


Locations(42)

Center for Inherited Blood Disorders

Orange, California, United States

University of Colorado Hemophilia and Thrombosis Center

Aurora, Colorado, United States

St Joseph's Children's Hospital of Tampa

Tampa, Florida, United States

Innovative Hematology, Inc.

Indianapolis, Indiana, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States

Arbesu Hematologia

Godoy Cruz, Mendoza Province, Argentina

Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli

Rosario, Santa Fe Province, Argentina

UZ Leuven

Leuven, Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Rigshospitalet

København Ø, Capital, Denmark

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, Val-de-Marne, France

Hospices Civils de Lyon

Bron, France

CHU de Lille - Institut Cœur Poumon

Lille, France

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Pest County, Hungary

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Central District, Israel

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Nagoya University Hospital

Nagoya, Aiti, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Ogikubo Hospital

Suginami-Ku, Tokyo, Japan

Universitair Medisch Centrum Utrecht Cancer Center - PPDS

Utrecht, Netherlands

Auckland City Hospital

Auckland, New Zealand

Haemophilia Comprehensive Care Centre

Parktown, Gauteng, South Africa

Kyungpook National University Hospital

Daegu, South Korea

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario La Paz - PPDS

Madrid, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

The Royal London Hospital

London, Middlesex, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

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