A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Condition(s) studied
Investigational drug(s) / intervention(s)
NXT007: NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
Emicizumab: Emicizumab will be administered subcutaneously (SC) using vial and syringe.
Study 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
Primary outcome measure(s)
- Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period — From Month 2 until the clinical cutoff date (at least 7 months of study treatment)
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| Center for Inherited Blood Disorders | Orange | California | Recruiting |
| University of Colorado Hemophilia and Thrombosis Center | Aurora | Colorado | Recruiting |
| University Of Miami Hospital | Miami | Florida | Recruiting |
| St Joseph's Children's Hospital of Tampa | Tampa | Florida | Recruiting |
| Innovative Hematology, Inc. | Indianapolis | Indiana | Recruiting |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | Recruiting |
| University of Michigan - 1500 E Medical Center Dr | Ann Arbor | Michigan | Recruiting |
| M Health Fairview - Pediatric Specialty Clinic-Discovery | Minneapolis | Minnesota | Recruiting |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | Recruiting |
| Washington Center for Bleeding Disorders | Seattle | Washington | Recruiting |
| Arbesu Hematologia | Godoy Cruz | Mendoza Province | Recruiting |
| Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli | Rosario | Santa Fe Province | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Royal Children's Hospital Melbourne - PIN | Parkville | Victoria | Recruiting |
| UZ Leuven | Leuven | Antwerp | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP | Ribeirão Preto | São Paulo | Recruiting |
| London Health Sciences Centre | London | Ontario | Recruiting |
| Peking Union Medical College Hospital - East Campus | Beijing | Beijing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Suspended |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | Recruiting |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | Recruiting |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Recruiting |
| Rigshospitalet | København Ø | Capital | Recruiting |
| AP-HP - Hôpital Bicêtre | Le Kremlin-Bicêtre | Val-de-Marne | Recruiting |
| Hospices Civils de Lyon | Bron | France | Recruiting |
| CHU de Lille - Institut Cœur Poumon | Lille | France | Recruiting |
| AP-HP - Hôpital universitaire Necker-Enfants malades | Paris | France | Recruiting |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | Recruiting |
| Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus | Debrecen | Pest County | Recruiting |
| St James's Hospital | Dublin | Ireland | Recruiting |
| The Chaim Sheba Medical Center - PPDS | Ramat Gan | Central District | Recruiting |
| Azienda Ospedaliera Universitaria Federico II | Naples | Campania | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Lombardy | Recruiting |
| IRCCS Istituto Clinico Humanitas | Rozzano | Lombardy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | Recruiting |
| Nagoya University Hospital | Nagoya | Aiti | Recruiting |
| Gunma University Hospital | Maebashi | Gunma | Recruiting |
| Nara Medical University Hospital | Kashihara-shi | Nara | Recruiting |
| Ogikubo Hospital | Suginami-Ku | Tokyo | Recruiting |
+ 19 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07416604 on ClinicalTrials.gov ↗ ← All trials in South Korea