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

Sponsor
Hoffmann-La Roche
Study ID
NCT07416526
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NXT007 — COMBINATION_PRODUCT
    NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
  • Human Coagulation Factor VIII — DRUG
    Factor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Sep 23, 2027
Completion
Sep 23, 2031

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main Study Treatment Period: NXT007 Prophylaxis
    Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.
  • Active Comparator: Main Study Treatment Period: FVIII SOC Prophylaxis
    Participants randomized to this arm will receive FVIII standard of care (SOC) prophylaxis for the main study treatment period.
  • Experimental: Open-Label Extension Period: NXT007 Prophylaxis
    After the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the FVIII arm will be able to switch to NXT007, in the open-label extension period.

Primary Outcome Measure

Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period [ Time Frame: 6 months ]

Central Contacts

  • Reference Study ID Number: WO45886 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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