Last updated 6 days ago
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
126 patients around the world
Available in Argentina, Brazil, United States
Hoffmann-La Roche
2Research sites
126Patients around the world
This study is for people with
Hemophilia
Hemophilia a
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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).
- 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).
Sites
Arbesú Hematología
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyZEBRHA 1
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Hemophilia a
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07416526
