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A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A

RecruitingPhase 3Ages 12 Years - anyAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of severe (FVIII:C \<1 IU/dL \[International Unit per decilitre\]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII * No documented inhibitor (i.e., \<0.6 BU/mL \[Bethesda unit per millilitre\]), FVIII half-life ≥6 hours, or FVIII recovery \>66% in the last 3 years prior to screening * Documented historical negative test for FVIII inhibitor (i.e., \<0.6 BU/mL) within 12 months prior to enrollment * Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening * Agreement to adhere to the contraception requirements (for potential participants with childbearing potential) Exclusion Criteria: * Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for anti-retroviral therapy to treat HIV * Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third- degree atrioventricular heart block) or ECG evidence or clinical history of prior myocardial infarction * Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)
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What it tests

  • NXT007
  • Human Coagulation Factor VIII
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Where

36 sites
University of Colorado Hemophilia and Thrombosis Center
Aurora, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
Arbesu Hematologia
Godoy Cruz, Argentina
Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli
Rosario, Argentina
Universitätsklinikum AKH Wien
Vienna, Austria
Hemocentro Da UNICAMP
Campinas, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, Brazil
Peking University People's Hospital
Beijing, China

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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