A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Partici… (NCT07416526) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Japan126 participantsStarted 2026-05-09
Plain-language summary
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 inhibitors. The study will include people aged ≥12 years old with severe or moderate congenital hemophilia A without inhibitors on previous FVIII prophylaxis treatment.
Who can participate
Age range12 Years
SexALL
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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 pri…
What they're measuring
1
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
Timeframe: 6 months
Trial details
NCT IDNCT07416526
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-09-23
Contact for this trial
Reference Study ID Number: WO45886 https://forpatients.roche.com/